Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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 kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... | 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 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. |
| 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. |
| 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 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufa... | 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 | 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 | Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceutic... | 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, 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 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/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 11, 2021 | Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India... | CGMP Deviations | Class II | Granules USA, Inc. |
| Jul 29, 2021 | Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Phar... | 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... |
| 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 | 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... |
| 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 | Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor,... | 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... |
| Jul 15, 2021 | Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendsh... | cGMP Deviations | Class II | API Solutions Inc. |
| Jul 15, 2021 | Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne ... | cGMP Deviations | Class II | API Solutions Inc. |
| Jul 14, 2021 | Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRU... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzo... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzon... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jun 30, 2021 | Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-ste... | CGMP Deviations: Does not meet monograph for denaturant. | Class II | Cascade Kelly Holdings LLC |
| Jun 30, 2021 | Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-ste... | CGMP Deviations: Does not meet monograph for denaturant. | Class II | Cascade Kelly Holdings LLC |
| Jun 29, 2021 | Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, R... | cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cak... | Class II | Eli Lilly & Company |
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.