Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Nicardipine HCl in all strengths, all doses, and all packaging. | 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 | 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 | 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 | Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Glycopyrrolate 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 | Midazolam HCl Injection 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 | 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 | 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 | HYDROmorphone HCl Injection in all strengths, all doses, and all packaging. | 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 | Ephedrine Sulfate Injection in all strengths, all doses, and all packaging. | 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 | Ketamine HCl 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 | Methadone HCl Injection in all strengths, all doses, and all packaging. | 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 | Labetalol HCl 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 | Lidocaine HCl 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 | 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 | Atropine Sulfate Injection 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 | 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 | 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 | Adenosine Injection 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 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 | Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all dos... | 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 | 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 | 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 | Dexamethasone Sodium Phosphate 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 20, 2017 | DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged... | Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Nov 30, 2017 | All sterile drug preparations remaining within expiry prepared from Sufentani... | Lack of sterility assurance. | Class II | Intrathecal Compounding Specialist, LLC |
| Nov 30, 2017 | All sterile drug preparations remaining within expiry prepared from Fentanyl ... | Lack of sterility assurance. | Class II | Intrathecal Compounding Specialist, LLC |
| Nov 30, 2017 | All sterile drug preparations remaining within expiry prepared from Hydromorp... | Lack of sterility assurance. | Class II | Intrathecal Compounding Specialist, LLC |
| Nov 30, 2017 | All sterile drug preparations remaining within expiry prepared from Morphine ... | Lack of sterility assurance. | Class II | Intrathecal Compounding Specialist, LLC |
| Nov 13, 2017 | 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Car... | Lack of Assurance of Sterility | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Nov 9, 2017 | GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118... | Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans | Class I | Kareway Products Inc |
| Oct 19, 2017 | morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL ... | Lack Of Assurance Of Sterility. | Class II | SCA Pharmaceuticals, LLC |
| Oct 19, 2017 | SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUC... | Lack Of Assurance Of Sterility. | Class II | SCA Pharmaceuticals, LLC |
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.