Browse Drug Recalls
2,157 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,157 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 2,157 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 24, 2026 | Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by:... | Cross Contamination with Other Products: Customer complaints for appearance of discolored tablet... | Class I | JB Chemicals and Pharmaceuticals Ltd |
| Jun 4, 2026 | Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels... | Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machin... | Class I | Haleon US Holdings LLC |
| Jun 3, 2026 | Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured ... | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetac... | Class III | Amneal Pharmaceuticals, LLC |
| Jun 1, 2026 | BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Pr... | Microbial Contamination of Non-Sterile Products | Class I | BEEKEEPER'S NATURALS USA INC. |
| May 22, 2026 | Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters... | Microbial contamination of sterile products | Class II | Zep Inc |
| 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 |
| Apr 8, 2026 | Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ ... | Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus... | Class I | Blaine Labs Inc |
| 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 |
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.