Browse Drug Recalls
2,151 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,151 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 2,151 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 17, 2021 | Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aero... | Chemical contamination: Presence of benzene | Class I | Blistex Inc |
| Oct 26, 2021 | artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ... | Chemical Contamination: presence of benzene, acetaldehyde, and acetal. | Class I | VIRGIN SCENT INC |
| Oct 4, 2021 | Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dro... | Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stabil... | Class II | Akorn, Inc. |
| Oct 1, 2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can,... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dis... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 ... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 1... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Sep 30, 2021 | Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 1... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 9, 2021 | Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only... | Microbial contamination of non-sterile products: Firm's testing found lots to exceed specificatio... | Class I | Jacobus Pharmaceutical Company Inc. |
| Aug 27, 2021 | Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG... | Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total a... | Class I | DuPont Nutrition USA, Inc |
| Aug 24, 2021 | Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laborator... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Aug 24, 2021 | Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Dist... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Aug 24, 2021 | Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Aug 24, 2021 | Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, ... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Aug 10, 2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... | Non-Sterility: firm's third party lab confirmed microbial contamination. | Class I | SterRx, LLC |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | Chemical Contamination: presence of benzene | Class I | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | Chemical Contamination: presence of benzene | Class I | Johnson & Johnson Consumer, Inc. |
| Jul 7, 2021 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, ... | Presence of Foreign Substance- Potential of metal contamination. | Class II | Aurobindo Pharma USA Inc. |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR... | Class I | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR... | Class I | Global Sanitizers LLC |
| May 11, 2021 | DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distribut... | Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label c... | Class I | DIBAR NUTRICIONAL S DE RL DE CV |
| Apr 27, 2021 | SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topi... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile To... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile T... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net W... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Top... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.3... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Mar 31, 2021 | Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufact... | Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiap... | Class II | Apotex Corp. |
| Mar 31, 2021 | Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 ... | Microbial Contamination of Non-Sterile Product | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.