Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 12, 2021 | QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 10/ATROPINE 0.15 INJ INJECTABLE, Rx only,... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 25 INJ**T 106** INJECTABLE, Rx on... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, T... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | HYDROXOCOBALAMIN 5,000MCG/ML INJ 5,000MCG/ML INJECTABLE, Rx only, Talon Compo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1.5/PGE-1 50 INJ **ST 1** INJECTABLE, Rx ... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.5MG/ML IN OIL INJECTABLE, Rx only... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 5 INJ INJECTABLE, Rx only, Talon... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 8, 2021 | Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured fo... | Out of specification result observed in a dissolution test at the 9-month long term stability tim... | Class II | Lupin Pharmaceuticals Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, 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 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottle... | Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 4, 2021 | Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dro... | Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stabil... | Class II | Akorn, 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 | 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 (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 (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 | 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 (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 | 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 | 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. |
| 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 (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 | 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. |
| Sep 30, 2021 | Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... | 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 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... | cGMP Deviations | Class II | Beiersdorf Inc |
| Sep 28, 2021 | The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL O... | Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Men... | Class II | Revive Personal Products Company |
| Sep 27, 2021 | Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 S... | Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of steril... | Class II | AMIVAS (US), LLC |
| Sep 27, 2021 | Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets... | Failed Dissolution Specifications | Class II | Strides Pharma Inc. |
| Sep 23, 2021 | Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Man... | Finished product specification did not meet USP specifications. | Class II | Monarch PCM, LLC |
| Sep 22, 2021 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx O... | Lack of Assurance of Sterility | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| Sep 22, 2021 | Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial... | Lack of Assurance of Sterility | Class II | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy |
| Sep 22, 2021 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) ... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 21, 2021 | Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bot... | Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained duri... | Class II | SigmaPharm Laboratories LLC |
| 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 17, 2021 | ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, I... | Lack of sterility assurance. | Class II | IntegraDose Compounding Services LLC |
| Sep 17, 2021 | ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Prod... | Lack of sterility assurance. | Class II | IntegraDose Compounding Services LLC |
| Sep 17, 2021 | GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each ... | Failed Dissolution Specifications: results were above specification. | Class II | American Health Packaging |
| Sep 17, 2021 | Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only,... | Defective container: Cracked vials leading to lack of sterility assurance | Class II | Fresenius Kabi USA LLC |
| 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 10, 2021 | Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufac... | Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the... | Class II | Piramal Critical Care, Inc. |
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.