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.

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DateProductReasonClassFirm
May 1, 2026 Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per c... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Amerisource Health Services LLC
May 1, 2026 Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per ca... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Amerisource Health Services LLC
Apr 27, 2026 Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: L... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Golden State Medical Supply Inc.
Apr 27, 2026 Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lan... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Golden State Medical Supply Inc.
Apr 24, 2026 Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lann... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Lannett Company Inc.
Apr 24, 2026 MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%),... Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. Class I Wisconsin Pharmacal Company
Apr 22, 2026 BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl ... Lack of assurance of Sterility: potential product contamination Class II CareFusion 213, LLC
Apr 22, 2026 BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl ... Lack of assurance of Sterility: potential product contamination Class II CareFusion 213, LLC
Apr 20, 2026 NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles,... Chemical contamination; presence of lead and lithium above specification Class II Acella Pharmaceuticals, LLC
Mar 3, 2026 HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) ... Chemical contamination: Presence of benzene Class II Owen Biosciences Inc.
Mar 3, 2026 SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 ... Chemical contamination: Presence of benzene Class II Owen Biosciences Inc.
Mar 3, 2026 SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles... Chemical contamination: Presence of benzene Class II Owen Biosciences Inc.
Mar 3, 2026 FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE A... Chemical contamination: Presence of benzene Class II Owen Biosciences Inc.
Dec 12, 2025 ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura... Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mo... Class I Medinatura New Mexico, inc.
Dec 12, 2025 ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, ... Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mo... Class I Medinatura New Mexico, inc.
Nov 21, 2025 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, pac... Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ... Class III Glenmark Pharmaceuticals Inc., USA
Nov 18, 2025 Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Phar... Cross Contamination with Other Products Class III Glenmark Pharmaceuticals Inc., USA
Nov 12, 2025 Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED ... Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis Class II Medical Products Laboratories, Inc.
Nov 6, 2025 Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only... Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Class I Fresenius Kabi USA, LLC
Oct 3, 2025 TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only,... Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets. Class II Advanced Pharmaceutical Technology, Inc.
Sep 12, 2025 Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl P... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Sep 12, 2025 Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Sep 12, 2025 Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 ... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Sep 12, 2025 mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Sk... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Sep 12, 2025 ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverl... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Sep 12, 2025 edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) ... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Aug 25, 2025 Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By T... Cross Contamination with Other Products. Class III Consumer Product Partners, LLC
Aug 25, 2025 TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distribu... Cross Contamination with Other Products. Class III Consumer Product Partners, LLC
Jul 30, 2025 NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 m... Microbial Contamination of Sterile Products: elevated endotoxin levels Class I GenoGenix LLC
Jul 17, 2025 KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL... Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... Class I DermaRite Industries, LLC
Jul 17, 2025 DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol ... Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... Class I DermaRite Industries, LLC
Jul 17, 2025 DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bott... Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... Class I DermaRite Industries, LLC
Jul 17, 2025 PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) ... Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... Class I DermaRite Industries, LLC
Jun 6, 2025 ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church ... Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. Class I Church & Dwight Inc
Jun 6, 2025 ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Dist... Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. Class I Church & Dwight Inc
Jun 6, 2025 Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET... Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. Class I Church & Dwight Inc
Jun 2, 2025 Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100... Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial... Class I Amneal Pharmaceuticals, LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, M... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx On... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx o... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Mar 21, 2025 Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manu... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Ma... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Via... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 21, 2025 Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf... Lack of Assurance of Sterility: Media fill with bacterial contamination Class II Somerset Therapeutics Private Limited
Mar 12, 2025 Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), D... Chemical contamination: Presence of benzene Class II Alchemee, LLC
Mar 12, 2025 Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 ... Chemical contamination: Presence of benzene Class II Alchemee, LLC
Mar 11, 2025 Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/A... Chemical contamination: presence of benzene Class II Fruit Of The Earth, Inc.
Mar 11, 2025 CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (... Chemical contamination: presence of benzene Class II Fruit Of The Earth, Inc.
Mar 5, 2025 La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treat... Chemical Contamination: This recall has been initiated due to detected trace levels of benzene. Class II L'Oreal USA

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.