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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.