Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
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 Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesci... Presence of Foreign Substance: Product complaint received for the presence of foreign material em... Class II Zydus Pharmaceuticals (USA) Inc
Mar 17, 2025 Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactu... Failed dissolution specifications: lower than specifications Class II BIOCON PHARMA INC
Mar 13, 2025 Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenma... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactu... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Man... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b)... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), ... LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium ... Class I Dr. Reddy's Laboratories, Inc.
Mar 13, 2025 Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufa... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, R... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactu... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactur... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured b... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottl... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: ... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count pack... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmar... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenma... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: ... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: ... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b).... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manuf... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, R... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: G... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufact... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmar... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactur... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: G... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenm... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottl... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), ... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufact... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured ... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenm... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottl... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 12, 2025 B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Z... cGMP deviations Class II KABANA SKIN CARE
Mar 12, 2025 In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spec... cGMP deviations Class II KABANA SKIN CARE
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 GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Su... cGMP deviations Class II KABANA SKIN CARE
Mar 12, 2025 Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Z... cGMP deviations Class II KABANA SKIN CARE
Mar 12, 2025 Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 ... Chemical contamination: Presence of benzene Class II Alchemee, LLC

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.