Browse Drug Recalls

3,371 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,371 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 3,371 FDA drug recalls.

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DateProductReasonClassFirm
Oct 26, 2021 Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongest... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (5... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongest... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 12, 2021 Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 coun... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II Lupin Pharmaceuticals Inc.
Oct 12, 2021 Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II Lupin Pharmaceuticals Inc.
Oct 12, 2021 Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II Lupin Pharmaceuticals Inc.
Oct 12, 2021 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same... Class II Teligent Pharma, Inc.
Oct 12, 2021 Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 coun... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II Lupin Pharmaceuticals Inc.
Oct 12, 2021 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same... Class II Teligent Pharma, Inc.
Oct 12, 2021 Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II Lupin Pharmaceuticals Inc.
Oct 5, 2021 Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole... CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within ... Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2021 LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 O... cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... Class II Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a... cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... Class II Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 13... cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... Class II Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a)... cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... Class II Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 O... cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... Class II Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist... cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... Class II Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, P... cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... Class II Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 1... cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots w... Class II Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, lab... cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... Class II Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, pa... cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... Class II Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 1... cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... Class II Bayer Healthcare Pharmaceuticals Inc.
Sep 30, 2021 Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... cGMP Deviations Class II Beiersdorf Inc
Sep 30, 2021 Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... cGMP Deviations Class II Beiersdorf Inc
Sep 30, 2021 Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... cGMP Deviations Class II Beiersdorf Inc
Sep 21, 2021 Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chl... CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or ... Class II Sanitor Corporation
Sep 15, 2021 Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per ... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II American Health Packaging
Sep 14, 2021 Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Di... CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. Class II Direct Rx
Sep 3, 2021 Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II Morton Grove Pharmaceuticals, Inc.
Sep 3, 2021 Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II Morton Grove Pharmaceuticals, Inc.
Sep 3, 2021 Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, M... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II Morton Grove Pharmaceuticals, Inc.
Aug 27, 2021 Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceutic... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manu... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmac... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufa... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactu... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufa... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 13, 2021 Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfiz... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 t... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfi... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 11, 2021 Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India... CGMP Deviations Class II Granules USA, Inc.
Jul 29, 2021 Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... Class II Teva Pharmaceuticals USA
Jul 29, 2021 Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY... Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. Class II PAI Holdings, LLC. dba Pharmaceutical Associate...

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.