Browse Drug Recalls

17,709 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,709 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 17,709 FDA drug recalls.

DateProductReasonClassFirm
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 24, 2026 Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin... Presence of particulate matter: a white thread-like structure in the cartridge Class II Lupin Pharmaceuticals Inc.
Apr 24, 2026 Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... Class II Teva Pharmaceuticals USA, Inc
Apr 23, 2026 Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactu... Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impu... Class II JB Chemicals and Pharmaceuticals Ltd
Apr 23, 2026 iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made... Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th... Class II Thea Pharma, Inc.
Apr 23, 2026 Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (1... Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th... Class II Thea Pharma, Inc.
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 21, 2026 Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr... CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class II Breckenridge Pharmaceutical, Inc.
Apr 21, 2026 Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in F... Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr... Class II Alcon Research LLC
Apr 21, 2026 GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: ... Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr... Class II Alcon Research 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 20, 2026 Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile... Lack of Assurance of Sterility Class II SCOPE HEALTH
Apr 17, 2026 FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nas... Lack of Assurance of Sterility Class II Harrow Eye LLC
Apr 16, 2026 Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, Fo... Labeling: Missing Label Class III American Regent, Inc.
Apr 14, 2026 Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufac... Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is ... Class III Premier Dental Products Co
Apr 13, 2026 busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufa... Subpotent drug Class III Unichem Pharmaceuticals USA Inc.
Apr 9, 2026 Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit d... Failed Capsule Specifications: Out of specification results obtained during routine stability tes... Class II The Harvard Drug Group LLC
Apr 8, 2026 Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only... Defective container: defect in a batch of bottle caps, specifically involving dislodged or missin... Class II Apotex Corp.
Apr 7, 2026 Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride... Failed PH Specifications Class III Water-Jel Technologies, LLC
Apr 7, 2026 Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Sing... This recall is being conducted due to out of specification assay results in a limited number of b... Class II Hikma Pharmaceuticals USA INC
Apr 6, 2026 DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchan... Lack of Assurance of Sterility: Potential leaks from perforations in bags. Class II Fresenius Medical Care Holdings, Inc.
Apr 6, 2026 DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchan... Lack of Assurance of Sterility: Potential leaks from perforations in bags. Class II Fresenius Medical Care Holdings, Inc.
Apr 6, 2026 Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton,... Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin Class II Teva Pharmaceuticals USA, Inc
Apr 2, 2026 Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Via... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials,... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL)... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Pre... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package... Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... Class II B BRAUN MEDICAL INC
Apr 2, 2026 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Bra... Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... Class II B BRAUN MEDICAL INC
Apr 2, 2026 LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medica... Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... Class II B BRAUN MEDICAL INC
Apr 2, 2026 DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical... Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... Class II B BRAUN MEDICAL INC
Apr 1, 2026 fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 ... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells phar... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg pe... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg ... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Sc... Failed Stability Specifications Class II Island Kinetics, Inc. d.b.a. CoValence Laborato...
Apr 1, 2026 EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MED... Lack of Assurance of Sterility Class II International Medication Systems Ltd.
Mar 31, 2026 Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmace... Subpotent drug Class III Avantor Performance Materials LLC
Mar 27, 2026 Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufac... cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... Class II Appco Pharma LLC
Mar 27, 2026 Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufa... cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... Class II Appco Pharma LLC
Mar 27, 2026 Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufac... cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... Class II Appco Pharma LLC
Mar 26, 2026 Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, ... Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than no... Class II Hetero Labs Limited (Unit V)
Mar 25, 2026 Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceutica... Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 25, 2026 Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceutica... Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 25, 2026 Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceutica... Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 25, 2026 Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polye... Lack of Assurance of Sterility Class II Preferred Pharmaceuticals, 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.