U.S Food and Drug Administration released Drug Recall List, check latest birth control recall list by the FDA. A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A pill recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. Drug recalls may be conducted on a company’s own initiative or by FDA request.
FDA’s role in a drug recall is to oversee a company’s strategy, assess the adequacy of the recall and classify the recall. The list below includes voluntary recalls in which public notification has been issued.
FDA Drug Recall List Since 2018
| Date | Brand Name(s) | Product Description | Recall Reason Description | Company Name |
|---|---|---|---|---|
| 8/23/2023 | Numerous brand names | Numerous human food, animal (pet) food, medical devices, and drug products | Potential Salmonella contamination and presence of rodent activity at the distribution center & temperature abuse | Inmar Supply Chain Solutions |
| 7/31/2023 | Lupin Pharmaceuticals, Inc. | Tydemy oral contraceptive | Out of Specification Results | Lupin Pharmaceuticals, Inc. |
| 7/7/2023 | Cipla | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) | Failure to deliver the recommended dose | Cipla |
| 6/14/2023 | Major Pharmaceuticals | Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mg | Packaging may contain incorrect product due to labeling mix-up | The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories |
| 5/19/2023 | G-SUPRESS DX | Cough Suppressant, expectorant, nasal decongestant pediatric drops | Packaging may contain incorrect product | NOVIS PR LLC |
| 5/19/2023 | G-SUPRESS DX | Cough Suppressant, expectorant, nasal decongestant pediatric drops | Device & Drug Safety/Mislabeling | NOVIS PR LLC |
| 5/4/2023 | Numerous Brands | Various human and animal drug products | As a result of a bankruptcy, the firm is removing several products from the market due to the discontinuation of the Quality program which would result in the company’s inability to assure that products meet the identity, strength, quality, and purity cha | Akorn Operating Company LLC |
| 5/4/2023 | Advil | Over-The-Counter Drugs | Product was stored outside of labeled temperature requirements. | Family Dollar |
| 4/28/2023 | Mayne Pharma Inc. | FENTANYL Buccal Tablets CII | Safety updates were omitted in the Product Insert/Medication Guide (MG) | Teva Pharmaceuticals USA |
| 4/26/2023 | Pro Power Knight Plus, NUX, Dynamite Super | Male enhancement capsules | Product contains undeclared tadalafil and sildenafil | Gadget Island, Inc. |
| 3/31/2023 | Camber | Atovaquone Oral Suspension | Potential Bacillus cereus Contamination | Camber Pharmaceuticals, Inc. |
| 3/28/2023 | Midwest Cleaning Solutions, Clean Pro Supply, SOFT HANDS | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution; Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution | Due to Presence of Methanol | Jarman’s Midwest Cleaning Systems, Inc. |
| 3/22/2023 | Ascend Laboratories | Dabigatran Etexilate Capsules, USP | Detection of N-nitroso-dabigatran (NDAB) Impurity | Ascend Laboratories LLC. |
| 3/3/2023 | Purely Soothing | 15% MSM Drops | Non-sterility | Pharmedica USA LLC |
| 3/2/2023 | Apotex | Brimonidine Tartrate Ophthalmic Solution, 0.15% | Potential lack of sterility. | Apotex Corp. |
| 2/24/2023 | Delsam Pharma’s | Artificial Eye Ointment | Due to possible microbial contamination | Global Pharma Healthcare |
| 2/21/2023 | nanoMaterials Discovery Corporation | Hand Sanitizer | Due to presence of methanol | nanoMaterials Discovery Corporation |
| 2/13/2023 | PrimeZEN | PrimeZEN Black 6000 male enhancement capsules | Product contains undeclared tadalafil and sildenafil | Volt Candy |
| 2/2/2023 | EzriCare & Delsam Pharma | Artificial Tears Lubricant Eye Drops | Potential microbial contamination | Global Pharma Healthcare |
| 2/1/2023 | IBSA | TIROSINT®-SOL (levothyroxine sodium) | Subpotency | IBSA Pharma Inc. |
| 1/30/2023 | Banana Boat | Hair & Scalp Spray SPF 30 | Due to presence of benzene | Edgewell Personal Care |
| 1/9/2023 | Spectrum | Epinephrine bulk API | Product discoloration | Spectrum Laboratory Products Inc. |
| 12/27/2022 | Accord | Daptomycin for Injection | Mislabeling | Accord Healthcare, Inc |
| 12/27/2022 | Hospira, Inc. | Vancomycin Injection | Presence of Visible Glass Particulates | Hospira, Inc. |
| 12/27/2022 | Multiple brand names | After Burn® Cream and First Aid Kits containing After Burn Cream | Product is contaminated with Bacillus licheniformis and Bacillus sonorensis. | GFA Production |
| 12/21/2022 | Lupin | Quinapril 20 and 40 mg tablets | Presence of nitrosamine impurity, N-Nitroso-Quinapril | Lupin Pharmaceuticals Inc. |
| 11/29/2022 | Exela | Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial | Vial Breakage | Exela Pharma Sciences, LLC |
| 11/7/2022 | Adam’s Polishes | Hand sanitizer | Presence of methanol | Adam’s Polishes, LLC |
| 10/25/2022 | Aurobindo Pharma USA, Inc. | Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90’s HDPE bottle | Due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril | Aurobindo Pharma USA, Inc. |
| 10/25/2022 | Mylan Institutional LLC | Octreotide Acetate Injection, 500 mcg/mL | Due to glass particulates | Mylan Institutional LLC, a Viatris company |
| 10/13/2022 | Exela & Civica | Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial | Vial Breakage | Exela Pharma Sciences, LLC |
| 9/29/2022 | Golden State Medical Supply, Incorporated | Clopidogrel 75mg Tablets, Atenolol 25mg Tablets | Due to Label Mix-up | Golden State Medical Supply, Incorporated |
| 9/28/2022 | My Stellar Lifestyle | Wonder Pill Capsules | Product contains undeclared tadalafil | Proper Trade LLC/My Stellar Lifestyle |
| 9/27/2022 | Auromedics | Acyclovir Intravenous Product | Presence of a dark red, brown and black particulate inside the vial | Eugia US LLC |
| 9/19/2022 | Antica Farmacista | Ocean Citron Hand Sanitizer | Product contains benzene | Salon Technologies International Inc. |
| 9/16/2022 | Colgate | Toothpaste | Product was stored outside of labeled temperature requirements | Family Dollar |
| 8/22/2022 | Hospira | Propofol Injection Emulsion, USP | Potential presence of visible particulate | Hospira, Inc., a Pfizer Company |
| 8/4/2022 | Major | Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension | Microbial contamination | Plastikon Healthcare, LLC |
| 8/4/2022 | Multiple brand names | Magnesium Citrate Saline Laxative Oral Solution | Microbial contamination with Gluconacetobacter liquefaciens | Vi-Jon, LLC |
| 8/3/2022 | Launch Sequence | Launch Sequence Aphrodisia and Euphoria Capsules | Contain Tadalafil | Loud Muscle Science, LLC |
| 8/2/2022 | SANGTER | SANGTER Energy Supplement, 3000mg | Undeclared Sildenafil | Distributor RFR, LLC |
| 7/29/2022 | Banana Boat | Hair & scalp sunscreen spray | Due to presence of benzene | Edgewell Personal Care Company |
| 7/26/2022 | Multiple Brands | Magnesium Citrate Saline Laxative Oral Solution | Potential Gluconacetobacter liquefaciens contamination | Vi-Jon, LLC |
| 7/25/2022 | Sustango | Dietary Supplement for Male Enhancement | Undeclared Tadalafil | Ultra Supplement LLC |
| 7/21/2022 | Multiple brands | Multiple OTC Medical Products | Products stored outside of temperature requirements | Family Dollar |
| 7/19/2022 | Dose Vital | Honey | Undeclared active pharmaceutical ingredient tadalafil | MKS Enterprise LLC |
| 7/15/2022 | Multiple brand names | Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor | Microbial contamination with Gluconacetobacter liquefaciens | Vi-Jon, LLC |
| 7/13/2022 | Hospira | Propofol Injection Emulsion, USP | Potential presence of visible particulate | Hospira Inc, A Pfizer Company |
| 7/6/2022 | Mylan Pharmaceuticals Inc. | Insulin Glargine (Insulin glargine-yfgn) Injection Pens | Potential for the label to be missing on some pens. | Mylan Pharmaceuticals Inc. |
| 6/29/2022 | Bryant Ranch Prepack Inc. | Morphine Sulfate 30 mg Extended-Release tablets | Incorrect labeling | Bryant Ranch Prepack Inc. |
| 6/22/2022 | CVS Health | Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor | Microbial contamination with Gluconacetobacter liquefaciens | Vi-Jon, LLC |
| 6/14/2022 | Arti King | Artri King Reforzado con Ortiga y Omega 3 | Undeclared Diclofenac and Dexamethasone | Latin Foods Market |
| 6/9/2022 | SnoreStop | Nasal spray | Due to microbial contamination identified as Providencia rettgeri. | Green Pharmaceuticals Inc |
| 6/8/2022 | Major | Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension | Due to microbial contamination | Plastikon Healthcare, LLC |
| 6/7/2022 | Allergy Bee Gone for Kids | Nasal Swab Remedy | Product contains elevated levels of Bacillus cereus | Buzzagogo Inc. |
| 5/28/2022 | Artri Ajo King | Joint supplements | Contains diclofenac | Walmart Inc. |
| 5/23/2022 | Teva | Anagrelide Capsules | Dissolution Test Failure | Teva Pharmaceuticals USA |
| 5/2/2022 | Fagron | SyrSpend SF 500mL and 4L | Potential contamination with Burkholderia gladioli | Fagron Inc. |
| 4/22/2022 | Pfizer | Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg | Due to N-Nitroso-Quinapril Content | Pfizer |
| 4/12/2022 | Mylan | Insulin Glargine (Insulin glargine-yfgn) Injection | Label may be missing on some vials | Mylan Pharmaceuticals, Inc. a Viatris Company |
| 4/1/2022 | F&S Medical Supply, dba Pink Toyz | Pink Pussycat Capsules | Undeclared Sildenafil | F&S Medical Supply, dba Pink Toyz |
| 4/1/2022 | Mickey Mouse, The Mandalorian | Hand Sanitizer | Presence of Methanol in Mickey Mouse and Presence of Benzene in The Mandalorian | Best Brands Consumer Products, Inc. |
| 3/30/2022 | Suave | Aerosol Antiperspirants | Elevated levels of benzene | Unilever |
| 3/29/2022 | Teva Pharmaceuticals | IDArubicin Hydrochloride Injection USP | Potential Particulate Matter (silica and iron oxide) | Teva Pharmaceuticals |
| 3/24/2022 | Major Pharmaceuticals | Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL | Microbial Contamination | Plastikon Healthcare, LLC |
| 3/22/2022 | Sandoz | Orphenadrine Citrate 100 mg Extended Release (ER) Tablets | Presence of a Nitrosamine Impurity | Sandoz, Inc. |
| 3/22/2022 | Adamis Pharmaceuticals Corporation | SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes | Potential clogging of the needle preventing the dispensing of epinephrine | Adamis Pharmaceuticals Corporation |
| 3/22/2022 | Accuretic, Greenstone Brand | Accuretic™ (quinapril HCl/hydrochlorothiazide); quinapril and hydrochlorothiazide; and quinapril HCl/hydrochlorothiazide tablets | Presence of a nitrosamine, N-nitroso-quinapril | Pfizer |
| 3/10/2022 | Olympia Pharmaceuticals | Compounded Injectables | Products are out of specification | Olympia Pharmacy |
| 3/7/2022 | Fresenius Kabi USA | Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial | Due to the presence of particulate matter found in reserve and/or stability sample vials | Fresenius Kabi, USA |
| 3/7/2022 | Tennessee Technical Coatings Corp. | Hand Sanitizer | Product contains methanol | Tennessee Technical Coatings Corp. |
| 3/3/2022 | B. Braun Medical Inc. | 0.9% Sodium Chloride for Injection USP 250ML in Excel | Fluid leakage and low fill volume may cause a lack in sterility | B. Braun Medical Inc. |
| 2/18/2022 | Numerous brand names | Numerous human food, animal (pet) food, medical devices, and drug products | Potential Salmonella contamination and presence of rodent activity at the distribution center | Family Dollar, Inc. |
| 2/16/2022 | Sure, Brut | Aerosol deodorant and antiperspirant sprays | Presence of benzene | TCP HOT Acquisition LLC dba HRB Brands |
| 2/10/2022 | Positive-Health | Rise Up Red Edition Capsules | Undeclared Tadalafil | Positive-Health |
| 2/9/2022 | Celebrate Today | Red Mammoth capsules | Undeclared Sildenafil and Tadalafil | Celebrate Today |
| 2/8/2022 | Your Favorite Shop | The Red Pill | Undeclared Tadalafil | Your Favorite Shop |
| 2/8/2022 | MAC DADDY | MAC DADDY RED and PURPLE DIETARY SUPPLEMENTS | Undeclared Sildenafil and/or Tadalafil | ABC SALES 1 INC |
| 2/4/2022 | MegMan | MegMan Performance Booster capsules | Undeclared Tadalafil | Junp LLC |
| 1/31/2022 | Hard Dawn | Hard Dawn Rise and Shine capsules | Undeclared Tadalafil | Esupplementsales, LLC |
| 1/28/2022 | Auromedics | Polymyxin B for Injection USP, 500,000 Units/Vial | Presence of Particulate Matter | AuroMedics Pharma LLC |
| 1/27/2022 | RevitaDerm | Wound Care Gel | May be contaminated with Bacillus cereus | Blaine Labs Company |
| 1/19/2022 | Semglee | Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens | Missing Label | Mylan Pharmaceutical Inc. |
| 1/12/2022 | Viona | Metformin Hydrochloride Extended-Release Tablets | N-Nitrosodimethylamine (NDMA) Impurity | Viona Pharmaceuticals, Inc. |
| 1/12/2022 | AVpak | Senna Syrup 5mL | Potential microbial contamination | Lohxa LLC |
| 12/30/2021 | Taro | Clobetasol Propionate | Presence of Ralstonia pickettii bacteria | Taro Pharmaceuticals USA, Inc. |
| 12/27/2021 | Perrigo | Nitroglycerin Lingual Spray | Unit may not properly dispense medication. | Padagis |
| 12/10/2021 | Rompe Pecho | Liquid Cold & Flu symptom relief | Microbial contamination | Efficient Laboratories, Inc |
| 12/7/2021 | Teligent Pharma, Inc. | Lidocaine HCl Topical Solution USP 4%, 50ml | Super potent | Teligent Pharma, Inc. |
| 12/7/2021 | Edge Pharma, LLC | All drugs compounded at Edge Pharma, LLC | Process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products | Edge Pharma, LLC |
| 12/3/2021 | Gilead | Veklury® (remdesivir 100 mg for injection) | Presence of glass particulates | Gilead Sciences Inc. |
| 12/2/2021 | Sandoz | Enoxaparin Sodium Injection | Exposure to high temperatures may have impacted product effectiveness. | Sandoz, Inc. |
| 11/23/2021 | Old Spice, Secret | Old Spice and Secret Aerosol Sprays | Due to the presence of benzene | The Proctor & Gamble Company |
| 11/22/2021 | Sagent | Levetiracetam Injection | Lack of sterility assurance | Sagent Pharmaceuticals, Inc. |
| 11/19/2021 | American Screening | Hand Sanitizer | Hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption | American Screening LLC |
| 11/17/2021 | Odor-Eaters® | Oder Eaters spray products | Due to the presence of benzene | Odor-Eaters®, owned by Blistex Inc. |
| 11/15/2021 | SterRx, LLC | SterRx products intended to be sterile | Lack of sterility assurance | SterRx, LLC |
| 10/27/2021 | artnaturals | Scent Free Hand Sanitizer | Due to Presence of Impurities | artnaturals |
| 10/20/2021 | CUBICIN | Daptomycin for injection 500mg | Product contains particulate matter identified as glass | Merck |
| 10/19/2021 | Bryant Ranch Prepack | Methocarbamol 500mg | Bottles labeled as Methocarbamol 500mg tablets were found to contain Methocarbamol 750mg tablets. | Bryant Ranch Prepack |
| 10/14/2021 | Lupin | Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg | API batches above the specification limit for the impurity, N-nitrosoirbesartan | Lupin Pharmaceuticals, Inc. |
| 10/12/2021 | Teligent Pharma, Inc. | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) | Super Potent | Teligent Pharma, Inc. |
| 10/1/2021 | Lotrimin® AF and Tinactin® | Over the Counter (OTC) antifungal spray products | Presence of benzene | Bayer U.S. LLC |
| 9/30/2021 | Coppertone | Coppertone aerosol sunscreen spray products | Presence of benzene | Coppertone, owned by Beiersdorf |
| 9/26/2021 | Lilly | Glucagon Emergency Kit | Loss of potency | Eli Lilly and Company |
| 9/21/2021 | IntegraDose Compounding Services, LLC | Cefazolin | Lack of sterility assurance. | IntegraDose Compounding Services, LLC |
| 9/16/2021 | CHANTIX | Varenicline tablets | N-nitroso-varenicline above acceptable daily intake level | Pfizer |
| 9/13/2021 | Ruzurgi® | Ruzurgi® (amifampridine) 10 mg tablets | Exceeds Specification for Total Yeast and Mold Counts | Jacobus Pharmaceutical Company Inc. |
| 9/8/2021 | Azurity | Firvanq | Product kit may contain incorrect diluent. | Azurity Pharmaceuticals, Inc. |
| 9/7/2021 | Hospira | Aminosyn II, 15%, An Amino Acid Injection, Sulfite | Presence of visible particulate matter | ICU Medical, Inc. |
| 9/3/2021 | Teligent | Lidocaine HCl Topical Solution 4% | Super potency | Teligent Pharma, Inc. |
| 8/16/2021 | CHANTIX | Smoking cessation treatment | N-Nitroso Varenicline content above acceptable daily intake level | Pfizer |
| 8/11/2021 | Max Health | Hydro Pineapple Burn | undeclared sibutramine | Ebay Seller-John Nguyen |
| 8/10/2021 | SterRx, LLC | Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL | Due to waterborne microbial contamination | SterRx, LLC |
| 7/19/2021 | CHANTIX | Smoking cessation treatment | N-Nitroso Varenicline content above ADI level | Pfizer |
| 7/14/2021 | Neutrogena, Aveeno | Sunscreen | Testing identified low levels of benzene | Johnson & Johnson |
| 7/13/2021 | Innoveix Pharmaceuticals, Inc. | Injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg | Potential lack of sterility assurance | Innoveix Pharmaceuticals, Inc. |
| 7/1/2021 | Teva | Topotecan Injection 4 mg/4 mL (1 mg/mL) | Presence of particulate matter | Teva Pharmaceuticals |
| 7/1/2021 | Limar | Hand sanitizer | Packaged in bottles that resemble drink containers | Ardil Commercial |
| 6/22/2021 | Prairie Wolf Distillery | Hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles | Packaged in containers resembling water bottles | Prairie Wolf Spirits, Inc. |
| 6/22/2021 | Durisan | Hand sanitizer and hand sanitizing wipes | Microbial contamination | Sanit Technologies LLC d/b/a Durisan |
| 6/11/2021 | Viona Pharmaceuticals Inc. | Metformin Hydrochloride Extended-Release Tablets | Contains Nitrosodimethylamine (NDMA) impurities | Viona Pharmaceuticals Inc. |
| 5/28/2021 | Imperia Elita | Imperia Elita Vitaccino Coffee | Undeclared Sibutramine and Fluoxetine | Dash Xclusive |
| 5/25/2021 | Medically Minded | Hand Sanitizer | Presence of methanol | Global Sanitizers |
| 5/19/2021 | DIBAR Labs, ProtectoRx | Hand Sanitizer | Presence of methanol | Dibar Nutricional S. de R.L. de C.V. |
| 5/17/2021 | Durisan | Hand sanitizer | Product is contaminated with Burkholderia contaminans | Sanit Technologies LLC d/b/a Durisan |
| 5/13/2021 | Medically Minded | Hand Sanitizer | Presence of methanol | Global Sanitizers |
| 5/13/2021 | Goose Creek, COCO TKO | Hand Sanitizer | Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde | Scentsational Soaps & Candles, Inc. |
| 5/12/2021 | DIBAR Labs, ProtectoRx | Hand Sanitizer | Presence of methanol | Dibar Nutricional S. de R.L. de C.V. |
| 5/11/2021 | Poseidon | Male Sexual Enhancement Dietary Supplement | Undeclared Tadalafil and Sildenafil | Yamtun7 |
| 5/10/2021 | Levemir, Tresiba, Fiasp, Novolog and Xultophy | Product Samples | Due to improper storage temperature conditions | Novo Nordisk |
| 5/4/2021 | Hospira, Inc. | 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and 1% Lidocaine HCl Injection, USP 30 mL | Due to mislabeling | Hospira, Inc. |
| 5/4/2021 | Hospira, Inc. | Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial | Due to visible particulate | Hospira, Inc. |
| 4/30/2021 | Acella | NP Thyroid (Thyroid Tablets, USP) | Sub potency | Acella Pharmaceuticals, LLC |
| 4/28/2021 | Ulta Beauty Collection & SS | Scented Hand Sanitizer | Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde | Scentsational Soaps & Candles, Inc. |
| 4/20/2021 | ChloraPrep | ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator | Defective applicator | Becton, Dickinson and Company |
| 4/16/2021 | Durisan | Hand sanitizer | Product is contaminated with Burkholderia contaminans | Sanit Technologies LLC d/b/a Durisan |
| 4/9/2021 | NS NY Distributor Inc | Premium Orgazen 7000 and Ginseng Power 5000 capsules | Undeclared Sildenafil and/or Tadalafil | NS NY Distributor Inc |
| 4/6/2021 | PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 | Dietary Supplement for male sexual enhancement | Undeclared Tadalafil | Yolo Studio |
| 4/5/2021 | IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 | Dietary Supplement for male sexual enhancement | Undeclared Sildenafil and/or Tadalafil | QMART |
| 4/2/2021 | A-S Medication Solutions, LLC | Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles contained in Health Essentials Kits distributed by Humana | Products contain an incomplete prescription drug label | A-S Medication Solutions, LLC |
| 3/31/2021 | Thumbs Up 7, Shogun-X, 69MODE | Dietary Supplement for male sexual enhancement | Undeclared Sildenafil, Tadalafil, Vardenafil | Nuri Trading LLC |
| 3/31/2021 | Apotex Corp. | Guanfacine Extended-Release Tablets 2mg | Trace amounts of Quetiapine Fumarate | Apotex Corp. |
| 3/31/2021 | Thumbs Up 7, Shogun, Krazy Night | Dietary Supplement for male sexual enhancement | Undeclared Sildenafil, Tadalafil, Vardenafil | Ummzy LLC |
| 3/30/2021 | Thumbs Up 7 | Blue 69K Dietary Supplement for male sexual enhancement | Undeclared Sildenafil and Tadalafil | Bit & Bet LLC |
| 3/29/2021 | Thumbs Up 7 | Dietary Supplement for male sexual enhancement | Undeclared Sildenafil and Tadalafil | Antoto-K |
| 3/26/2021 | PremierZen | Dietary Supplement for male sexual enhancement | Undeclared Sildenafil and Tadalafil | Namoo Enterprise LLC |
| 3/25/2021 | Zydus Pharmaceuticals | Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials | Due to Crystalization | Zydus Pharmaceuticals Inc. |
| 3/25/2021 | Imperial | Dietary Supplement for Male Enhancement | Undeclared Sildenafil & Tadalafil | S&B Shopper LLC |
| 3/24/2021 | Alembic | Telmisartan Tablets, USP, 20 mg | Incorrect Product Strength on Label | Alembic Pharmaceuticals, Inc. |
| 3/24/2021 | Durisan | Antimicrobial Hand Sanitizer | Due to microbial contamination | Sanit Technologies LLC d/b/a Durisan |
| 3/24/2021 | ChloraPrep; BD ChloraPrep | ChloraPrep 3 mL Applicator | Potential Aspergillus penicillioides contamination | (Becton, Dickinson and Company) |
| 3/17/2021 | Heal the World | Hand Sanitizer | Because they resemble water bottles; risk of ingestion | PNHC, LLC d/b/a Heal the World |
| 3/11/2021 | Sagent | Phenylephrine Hydrochloride Injection | Lack of sterility assurance | Sagent Pharmaceuticals, Inc. |
| 3/9/2021 | BRP Pharmaceuticals | Spironolactone TB 25MG and 50MG | Incorrect strength displayed on the label | Bryant Ranch Prepack |
| 2/16/2021 | Adam’s Secret | Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules | Product contains undeclared sildenafil and/or tadalafil | Adamssecret.co |
| 2/3/2021 | Apotex Corp. | Enoxaparin Sodium Injection, USP | Packaging error resulting in incorrect dosage listed | Apotex Corp |
| 1/27/2021 | Meitheal Pharmaceuticals, Inc. | Cisatracurium Besylate Injection, USP 10mg per 5mL | Mislabeling | Meitheal Pharmaceuticals, Inc. |
| 1/25/2021 | Nostrum Laboratories, Inc. | Metformin HCl Extended Release Tablets, USP 750 mg | Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day | Nostrum Laboratories, Inc. |
| 1/8/2021 | Fresenius Kabi | Ketorolac Tromethamine Injection, USP, 30 mg/mL | Presence of particulate matter | Fresenius Kabi USA |
| 1/4/2021 | Soho Fresh | 70% Rubbing Alcohol | Contaminated with Methanol | Essaar Inc. |
| 1/4/2021 | Nostrum Laboratories | Metformin HCl Extended Release Tablets, USP 750 mg | NDMA exceeds acceptable daily intake limit | Nostrum Laboratories |
| 12/31/2020 | GUM Paroex | Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups | Potential contamination with Burkholderia lata | Precision Dose Inc. |
| 12/2/2020 | MPM Medical | Regenecare HA Topical Anesthetic Hydrogel | Burkholderia cepecia contamination. | MPM Medical, LLC |
| 11/23/2020 | CORE, Immune Boost | CORE essential nutrients and Immune Boost Sublingual Vitamin D3 | Unapproved new drug | Fusion Health and Vitality LLC |
| 11/19/2020 | Fresenius Kabi USA | Dexmedetomidine HCL in 0.9% Sodium Chloride Injection | Cross Contamination with Lidocaine | Fresenius Kabi USA |
| 11/9/2020 | Lohxa | Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free | May be contaminated with Burkholderia lata | Lohxa, LLC |
| 11/3/2020 | Nostrum Laboratories | Metformin HCl Extended Release Tablets, USP 500 mg | NDMA exceeds acceptable daily intake limit | Nostrum Laboratories |
| 9/23/2020 | Riomet ER | Metformin Hydrochloride for Extended-Release Oral Suspension | Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity | Sun Pharmaceutical Industries |
| 9/17/2020 | NP Thyroid 15 & NP Thyroid120 | Thyroid Tablets | Sub Potency | Acella Pharmaceuticals, LLC |
| 9/3/2020 | Leafree | Hand sanitizer | Product is labeled as edible alcohol. | CorgioMed LLC |
| 9/1/2020 | Red-E | Red-E male enhancement tablet | Product contains undeclared sildenafil | The Protein Shoppe, LLC |
| 8/25/2020 | V-Klean, Medical Minded, Protz | Hand Sanitizer | Potential presence of methanol (wood alcohol) and subpotent ethanol levels | Asiaticon SA de CV |
| 8/18/2020 | Yacana | Yacana Hand Sanitizer, 70% Alcohol | Potential Presence of Methanol (Wood Alcohol) and sub-potent ethanol | Grupo Yacana México S.A.S de C.V. |
| 8/15/2020 | SkinGuard24 | All Day Hand Sanitizer | Contains Methanol | SG24 LLC |
| 8/10/2020 | (Becton, Dickinson and Company) | ChloraPrep™ 3 mL applicator | Potential fungal contamination – Aspergillus penicillioides | (Becton, Dickinson and Company) |
| 8/4/2020 | Command Brands | Hand Sanitizer | Methanol Contamination | Roque Plast S.A. de C.V. |
| 8/1/2020 | Jaloma | Hand Sanitizer | Undeclared Methanol | Laboratorios Jaloma S.A. de C.V. |
| 7/28/2020 | KORE ORGANIC | Watermelon CBD oil tincture | Contains lead | Summitt Labs |
| 7/24/2020 | Born Basic, Scent Theory and more | Hand Sanitizer | Undeclared methanol | Real Clean Distribuciones SA de CV |
| 7/22/2020 | Fresenius Kabi | Dexmedetomidine Hydrochloride Injection, 200 mcg/50 mL | Cross contamination with lidocaine | Fresenius Kabi USA |
| 7/14/2020 | Bersih | Hand Sanitizer Gel | Potential Methanol Contamination | Soluciones Cosmeticas |
| 7/8/2020 | Lupin | Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg | N-Nitrosodimethylamine (NDMA) Impurity | Lupin Pharmaceuticals, Inc. |
| 7/7/2020 | Mylan | Daptomycin for Injection | Presence of particulate matter | Mylan Institutional LLC |
| 6/18/2020 | Robitussin | Cough and cold products | Incorrect dosing cups | GSK Consumer Healthcare |
| 6/11/2020 | Lupin | Metformin Hydrochloride Extended-release Tablets | Detection of N-Nitrosodimethylamine (NDMA) | Lupin Pharmaceuticals, Inc |
| 5/22/2020 | Acella | 30-mg, 60-mg and 90-mg NP Thyroid® | Super potency | Acella Pharmaceuticals, LLC |
| 5/8/2020 | ICU Medical Inc. | Lactated Ringer’s Injection, USP | Presence of particulates (iron oxide) | ICU Medical Inc. |
| 4/27/2020 | QuVa | R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe | presence of particulate matter | QuVa Pharma, Inc. |
| 4/20/2020 | B. Braun | Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container | Out-of-Specification Results for High Molecular Weight Polymers | Braun Medical Inc |
| 4/16/2020 | Heritage | Tetracycline HCl Capsules, 250mg and 500mg | Due to low out of specification dissolution results | Avet Pharmaceuticals Labs Inc. |
| 4/15/2020 | Gemini Laboratories | Nizatidine Oral Solution 15 mg/mL | NDMA (Nitrosodimethylamine) impurity | Amneal Pharmaceuticals, LLC |
| 3/27/2020 | Taytulla | Birth control capsules | Due to Out of Sequence Capsules | Allergan |
| 3/26/2020 | Dr. Reddy’s Laboratories Ltd. | Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules | Ampules breaking & shattering | Dr. Reddy’s Laboratories Ltd. |
| 3/23/2020 | Ranier’s RX Laboratory | Compounded drug products | Due to Lack of Sterility Assurance | Ranier’s RX Laboratory |
| 3/19/2020 | Children’s Advil | Ibuprofen Oral Suspension | Dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL) | Pfizer, Inc. |
| 3/19/2020 | Neuroveen, Respitrol, Thyroveev, Compulsin | Homeopathic Medicines | Due to Possible Microbial Contamination | HelloLife, Inc. |
| 3/19/2020 | CVS, Rhinall, Humist, more | Nasal Products and Baby Oral Gels | Microbial Contamination | Product Quest Manufacturing LLC |
| 3/19/2020 | Beaumont Bio Med Homeopathic | Homeopathic oral sprays | Due to Possible Microbial Contamination | Beaumont Bio Med, Inc. |
| 3/17/2020 | Zero Xtreme | Dietary Supplement for Weight Loss | Due to Presence of Undeclared Sibutramine | Fat Burners Zone |
| 3/16/2020 | Natural Remedies | Active Male capsules | Presence of Undeclared Tadalafil | Natural Remedy Store |
| 3/16/2020 | Puriton | Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle | Due to Non-Sterile Production Conditions | Kadesh Inc. |
| 3/11/2020 | Family Wellness, CVS, Equate | Infants’ Ibuprofen | Due to Potential Higher Concentrations of Ibuprofen | Tris Pharma |
| 3/10/2020 | Lubrisine | Eye Drops | Sterility Concerns and Undeclared Colloidal Silver | Results RNA LLC |
| 3/5/2020 | West-Ward | Ketorolac Tromethamine Injection, USP 30mg/mL, 1 mL Vial | Potential Presence of Small Particulates | Hikma Pharmaceuticals USA Inc. |
| 1/8/2020 | Mylan | Nizatidine Capsules 150mg and 300mg | NDMA (Nitrosodimethylamine) impurity | Mylan N.V. |
| 12/17/2019 | No Brand name Listed on Package | Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, Panther Platinum 30000 | Presence of Undeclared Tadalafil | Motto International Corp |
| 11/19/2019 | PrecisionDose | Ranitidine Oral Solution, USP 150 mg/10 mL | Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA | Precision Dose Inc. |
| 11/8/2019 | AHP | Ranitidine Liquid Unit Dose Cups | NDMA (Nitrosodimethylamine) impurity | American Health Packaging |
| 10/30/2019 | ICU Medical, Inc. | Lactated Ringer’s Injection, USP and 0.9% Sodium Chloride Injection, USP | Due to the presence of particulate matter | ICU Medical, Inc. |
| 9/23/2019 | Sandoz Inc. | Ranitidine Hydrochloride Capsules | Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) | Sandoz Inc. |
| 9/16/2019 | Macho | MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT | Undeclared Tadalafil | Fitoterapia USA Inc. |
| 9/5/2019 | Natpara | Parathyroid Hormone for Injection | Potential presence of rubber particulate | Takeda Pharmaceutical Company Limited |
| 7/23/2019 | Cadista | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg | Due to out of specification (OOS) dissolution results at the 3-month stability time point | Jubilant Cadista Pharmaceuticals Inc. |
| 6/26/2019 | Macleods | Losartan Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination tablets | Presence of NMBA impurity | Macleods Pharmaceutical Limited |
| 6/18/2019 | RXQ Compounding LLC | All sterile human and animal products within expiry. | Lack of Sterility Process Assurance | RXQ Compounding LLC |
| 5/29/2019 | Pecgen DMX, | PECGEN DMX, 16 oz, liquid cough syrup | Incorrect dosage on label | NOVIS PR LLC |
| 5/23/2019 | Pharm D Solutions | Sterile Compounded Drug Products | Lack of sterility assurance | Pharm D Solutions, LLC |
| 3/15/2019 | Hospira | Sodium bicarbonate injection USP | Presence of Particulate Matter | Hospira, Inc. |
| 2/25/2019 | Golean Detox | Dietary Supplement for Weight Loss | Mislabeling | Golean Detox USA |
| 2/4/2019 | Dr. Reddy’s Laboratories Ltd. | Infusion Bags (Levetiracetram in 0.54% Sodium Chloride Injection) | Mislabeling | Dr. Reddy’s Laboratories Ltd. |
| 1/29/2019 | CVS, Equate | Oral ibuprofen | Higher Concentration of Ibuprofen | Tris Pharma, Inc. |
| 1/8/2019 | Rhino | Rhino 5K capsules | Undeclared Sildenafil and Tadalafil | Happy Together, Inc. |
| 1/8/2019 | Sun Pharma | Vecuronium Bromide for Injection | Potential Foreign Material | Sun Pharmaceutical Industries, Inc |
| 6/21/2018 | Gaia Ethnobotanical | Kratom Products | Salmonella | Gaia Ethnobotanical, LLC |
| 2/9/2018 | LaBri’s Body Health | Dietary Supplement | Mislabeling | Envy Me |
| 2/8/2018 | LaBri’s Body Health | Dietary Supplement | Due to presence of Sibutramine | EZ Weight Loss TX |
| 2/8/2018 | Bristol-Myers Squibb | Eliquis (apixaban) 5 mg Tablets | Potential Labeling Issue | Bristol-Myers Squibb |
| 2/8/2018 | Baxter | intravenous (IV) solutions: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container and 70% Dextrose Injection (2000 mL) USP | Labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets | Baxter International Inc. |
| 2/8/2018 | Amneal Pharmaceuticals LLC | Lorazepam Oral Concentrate, USP 2mg/mL | Due to Misprinted Dosing Droppers | Amneal Pharmaceuticals LLC |
| 2/6/2018 | Caverflo | Natural Herbal Coffee | Undeclared Active Pharmaceutical Ingredients and Undeclared Milk | Caverflo.com |
Latest Birth Control Recall by FDA
Birth control pills have been recalled after testing revealed a problem that might critically reduce how well they work — but the recalling company says to keep taking them until you find a replacement. These messages come in an FDA-posted recall notice from Lupin Pharmaceuticals, which yanked two lots of Tydemy oral contraceptive after one lot “tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.” This is a problem, Lupin explains, because “if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy.”
Lot No. L200183 with an expiration of January 2024 was the lot tested. The other lot recalled is No. L201560 with an expiration of September 2024. Each lot includes both NDC Nos. 68180-904-71, one blister pack of 28 tablets, and 68180-904-73, three blister packs of 28 tablets each.
Classification of Drug Recall List
- Class I: A dangerous or defective product that could cause serious health problems or death.
- Class II: A product that might cause a temporary health problem, or pose slight threat of a serious nature.
- Class III: A products that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.
Alerting the Public
Not all recalls are announced on FDA.gov or in the news media. Public notification is generally issued when a product that has been widely distributed or poses a serious health hazard is recalled. However, if a company does not issue public notification of a recall, FDA may do so if the agency determines it is necessary to protect patients. Patients also may learn that their medicine has been recalled through notification from the manufacturer, their health care professional or pharmacist.
If you have a medicine that has been recalled, talk to your health care professional about the best course of action for your health, including the possibility of returning the product to the store in which you purchased it. Stores generally have a return and refund policy when a company has announced a recall of its products. Generally, Class I recall notifications provide instructions with actions for patients. FDA recommends that patients follow the instructions provided by the recalling company.
Also Read: List of Birth Control Side Effects
Weekly Enforcement Report
All recalls are posted weekly in the FDA enforcement report. Recalls that are classified will have a classification of Class I, Class II or Class III based on the level of hazard. Ongoing recalls that have not been classified are also published in the enforcement report as “not yet classified” in the classification field. After the recall classification has been determined, the recall is updated in the enforcement report with its appropriate classification.
Determining the Effectiveness of the Recall
A drug recall is an action taken by a pharmaceutical company or a regulatory agency to remove a particular medication from the market or pharmacy shelves. This action is usually initiated when there are concerns about the safety, efficacy, or quality of a specific drug product. The recall process aims to protect the public from potential harm that could arise from using the medication in question.
Drug recalls can be voluntary or mandated by regulatory authorities. There are several reasons for a drug recall, including contamination, manufacturing defects, labeling errors, adverse reactions, outdated or expired products. FDA evaluates the effectiveness of a recall by evaluating a company’s efforts to properly notify customers and remove the defective product from the market. If a recall is determined to be ineffective FDA will request the company take additional actions.
See Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products. For FDA drug recall notices older than 60 days, see recall and safety alerts archive.
