Browse Drug Recalls

2,138 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,138 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 2,138 FDA drug recalls.

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DateProductReasonClassFirm
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
Mar 4, 2025 Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, ... Cross Contamination Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 4, 2025 Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, N... Cross Contamination Class III SUN PHARMACEUTICAL INDUSTRIES INC
Feb 28, 2025 Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT... Chemical Contamination: Presence of benzene Class II Sigan Industries Group Inc.
Feb 24, 2025 Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35... Chemical Contamination: Presence of benzene. Class II Denison Pharmaceuticals, LLC
Feb 14, 2025 BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and... Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. Class I CareFusion 213, LLC
Feb 13, 2025 Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide... Chemical Contamination Class II Johnson, S C and Son, Inc
Feb 13, 2025 Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxid... Chemical Contamination Class II Johnson, S C and Son, Inc
Jan 28, 2025 SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium... Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus Class I Ascent Consumer Products Inc.
Jan 28, 2025 SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 m... Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus Class I Ascent Consumer Products Inc.
Jan 28, 2025 SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP... Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus Class I Ascent Consumer Products Inc.
Sep 17, 2024 Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distribu... Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with C... Class I Bionpharma Inc.
Sep 3, 2024 Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc ... Microbial Contamination of Non-Sterile Product Class II Vivier Pharma, Inc.
Aug 28, 2024 BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML... Microbial contamination of non-sterile Products - Class II PREQUEL SKIN

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.