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
Oct 10, 2025 Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g pe... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% an... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 O... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT.... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 9, 2025 Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51... CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. Class II Breckenridge Pharmaceutical, Inc.
Oct 9, 2025 Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it c... Class II Amerisource Health Services LLC
Oct 7, 2025 Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHA... CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... Class II Teva Pharmaceuticals USA, Inc
Oct 7, 2025 Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHA... CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... Class II Teva Pharmaceuticals USA, Inc
Oct 7, 2025 Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHA... CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... Class II Teva Pharmaceuticals USA, Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-58... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-5... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-58... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-58... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-57... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Sep 29, 2025 Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl A... cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol co... Class II Acuity Specialty Products, Inc.
Sep 29, 2025 AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by... cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol co... Class II Acuity Specialty Products, Inc.
Sep 25, 2025 Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, ... cGMP deviations: the firm released and distributed product which failed total aerobic microbial c... Class II SV Labs Prescott Corporation
Sep 23, 2025 Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL b... CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. Class II Park Avenue Compounding
Sep 17, 2025 Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue... CGMP Deviations Class II Park Avenue Compounding
Sep 17, 2025 Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured ... CGMP Deviations: Market complaints received for gritty texture (grainy) Class II Glenmark Pharmaceuticals Inc., USA
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) ... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) bli... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) b... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) ... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) ... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 5, 2025 Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, ... cGMP deviations: Temperature excursion during transportation. Class II Sandoz Inc
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... Class II Zydus Pharmaceuticals (USA) Inc
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... Class II Zydus Pharmaceuticals (USA) Inc
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... Class II Zydus Pharmaceuticals (USA) Inc
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... Class II Zydus Pharmaceuticals (USA) Inc
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... Class II Zydus Pharmaceuticals (USA) Inc
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only,... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... Class II Zydus Pharmaceuticals (USA) Inc
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, ... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... Class II Zydus Pharmaceuticals (USA) Inc
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... Class II Zydus Pharmaceuticals (USA) Inc
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... Class II Zydus Pharmaceuticals (USA) Inc
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... Class II Zydus Pharmaceuticals (USA) Inc
Aug 27, 2025 DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in ... CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... Class II DermaRite Industries, LLC
Aug 27, 2025 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) ... CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... Class II DermaRite Industries, LLC
Aug 27, 2025 McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1),... CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... Class II DermaRite Industries, LLC
Aug 27, 2025 Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) ... CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... Class II DermaRite Industries, LLC
Aug 27, 2025 Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-... CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... Class II DermaRite Industries, LLC
Aug 27, 2025 Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102... CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... Class II DermaRite Industries, LLC
Aug 27, 2025 GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924... CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... Class II DermaRite Industries, LLC
Aug 27, 2025 UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 ... CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... Class II DermaRite Industries, LLC
Aug 27, 2025 San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Indust... CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... Class II DermaRite Industries, LLC
Aug 27, 2025 Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ell... cGMP violations Class II Atlantic Management Resources 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.