Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 9, 2018 | Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Jan 9, 2018 | Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Jan 5, 2018 | MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (US... | Subpotent | Class I | Advanced Pharma Inc. |
| Jan 4, 2018 | Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: In... | LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogr... | Class I | International Laboratories, LLC |
| Jan 3, 2018 | Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, M... | Failed Dissolution Specifications: Low out of specification results for dissolution during annual... | Class II | AVKARE Inc. |
| Jan 2, 2018 | Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for in... | Presence of Particulate Matter: A confirmed customer report was received for the presence of visi... | Class I | Aurobindo Pharma Ltd. |
| Dec 28, 2017 | Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe a... | Microbial Contamination of Non-Sterile Products. | Class II | DLC Laboratories, Inc |
| Dec 27, 2017 | Glycopyrrolate in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and al... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Fentanyl Citrate Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Labetalol HCl in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Ephedrine Sulfate Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pac... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and pack... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all ... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Succinylcholine Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packag... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all ... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Adenosine Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and a... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and al... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Rocuronium Bromide in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and al... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | HYDROmorphone HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Atropine Sulfate Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Ketamine HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Esmolol HCl in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Neostigmine Methylsulfate Injection in all strengths, all doses, and all pack... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Lidocaine HCl in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all dos... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all p... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Methadone HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Midazolam HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Nicardipine HCl in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Ropivacaine HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 22, 2017 | Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for... | Presence of foreign substance: metallic razor blade was found in one bottle. | Class III | Hetero Labs, Ltd. - Unit III |
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.