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
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
Aug 1, 2024 Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1... Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Class I Baxter Healthcare Corporation
Jul 2, 2024 Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... Cross contamination with other products Class III Zydus Pharmaceuticals (USA) Inc
Jul 2, 2024 Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... Cross contamination with other products Class III Zydus Pharmaceuticals (USA) Inc
Jul 2, 2024 Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Singl... Cross contamination with other products. Class III Zydus Pharmaceuticals (USA) Inc
Jul 2, 2024 Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a)... Cross contamination with other products. Class III Zydus Pharmaceuticals (USA) Inc
Jun 10, 2024 Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), p... Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination Class II Brands International Corporation
Jun 5, 2024 STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distri... Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms Class I Homeocare Laboratories, Inc.
Jun 5, 2024 STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473... Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism Class II Homeocare Laboratories, Inc.
May 24, 2024 suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broa... Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) Class I SYNCHRONICITY SPA INC, DBA SUNTE
May 1, 2024 CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Fl... Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria Class II Pharma Nobis LLC
May 1, 2024 Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free G... Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria Class II Pharma Nobis LLC
Apr 9, 2024 Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only,... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 5... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, ... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only,... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Mar 28, 2024 Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cart... Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. Class I AvKARE
Mar 23, 2024 Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle,... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Mar 23, 2024 Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Mar 4, 2024 Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufact... Cross Contamination with Other Products:(mycophenolate mofetil). Class III Novitium Pharma LLC
Mar 4, 2024 Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 4, 2024 Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Feb 1, 2024 TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 o... Chemical Contamination; presence of benzene. Class I Insight Pharmaceuticals LLC, a Prestige Consume...
Jan 18, 2024 Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hou... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, D... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distr... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablet... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distri... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Dec 28, 2023 Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guai... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma Inc.
Dec 28, 2023 Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydro... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma Inc.
Dec 28, 2023 Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump M... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma Inc.
Dec 28, 2023 Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydro... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma 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.