Browse Drug Recalls

3,368 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,368 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 3,368 FDA drug recalls.

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DateProductReasonClassFirm
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottl... 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 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... 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 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 Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmar... 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 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, 20mg, a).90-count bottle, Rx Only, Mfd for: ... 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 Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count pack... 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 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 Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactu... 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 Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, R... 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 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 Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactu... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
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 Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Man... 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 Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured... 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 Fenofibrate Capsules 67 mg, USP, 100-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 Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufa... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
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 B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Z... 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 GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Su... cGMP deviations Class II KABANA SKIN CARE
Mar 11, 2025 chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bo... CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended in... Class II Glenmark Pharmaceuticals Inc., USA
Mar 7, 2025 Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 6... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Direct Rx
Mar 7, 2025 Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: ... CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. Class II Slate Run Pharmaceuticals
Mar 7, 2025 Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: ... CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. Class II Slate Run Pharmaceuticals
Mar 7, 2025 Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distribu... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Direct Rx
Mar 5, 2025 Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only,... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class II Rising Pharma Holding, Inc.
Mar 5, 2025 La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System... cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific l... Class II L'Oreal USA
Mar 5, 2025 La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treat... cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific l... Class II L'Oreal USA
Mar 4, 2025 Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, ... CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable int... Class II Chattem Inc
Feb 28, 2025 Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, ... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Breckenridge Pharmaceutical, Inc.
Feb 28, 2025 Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, ... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Breckenridge Pharmaceutical, Inc.
Feb 28, 2025 Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, M... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Breckenridge Pharmaceutical, Inc.
Feb 28, 2025 Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 5... CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... Class II Glenmark Pharmaceuticals Inc., USA
Feb 28, 2025 Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01... CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... Class II Glenmark Pharmaceuticals Inc., USA
Feb 28, 2025 Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: G... CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... Class II Glenmark Pharmaceuticals Inc., USA
Feb 28, 2025 Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Gl... CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... Class II Glenmark Pharmaceuticals Inc., USA
Feb 12, 2025 ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Steri... Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. Class II Wuxi Medical lnstrument Factory Co., Ltd.

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.