Browse Drug Recalls

1,327 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,327 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 1,327 FDA drug recalls in IL.

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DateProductReasonClassFirm
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Sin... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Sin... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Sing... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Feb 21, 2018 Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Onl... Failed Stability Specification: OOS low viscosity results discovered during retain testing. Class III Akorn, Inc.
Feb 15, 2018 PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodi... Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. Class II Medline Industries Inc
Jan 22, 2018 Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Mar... Labeling: Label Error on Declared Strength Class II Astellas Pharma US Inc
Jan 22, 2018 Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by... Defective container: presence of a hole in the liners of the caps covering the product bottle, in... Class III AbbVie Inc.
Jan 16, 2018 Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius K... Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related ... Class III Fresenius Kabi USA, 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 Dexamethasone Sodium Phosphate 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 Nicardipine HCl 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 Methadone HCl Injection in all strengths, all doses, and all packaging. 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 added to 5% Dextrose in all strengths, all dos... 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 Neostigmine Methylsulfate Injection in all strengths, all doses, and all pack... 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 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 Atropine Sulfate Injection in all strengths, all doses, and all packaging. 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 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 in 5% Dextrose in all strengths, all doses, and all packaging. 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 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 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 Rocuronium Bromide in all strengths, all doses, and all packaging. 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 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 Adenosine Injection 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 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 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 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 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 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 Succinylcholine Chloride 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 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 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 Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths... 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 Ephedrine Sulfate 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 Fentanyl Citrate Injection in all strengths, all doses, and all packaging. 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 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 Glycopyrrolate in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, 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.