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Browse Drug Recalls

115 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 115 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 115 FDA drug recalls.

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DateProductReasonClassFirm
Aug 19, 2015 Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharma... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syring... Subpotent drug. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, ... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 m... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syring... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, ... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in s... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL i... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Apr 21, 2014 Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx ... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Ph... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharma... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class II Pharmakon Pharmaceuticals
Mar 26, 2014 Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per... Superpotent Drug: Product contains twice the stated amount of midazolam. Class I Pharmakon Pharmaceuticals

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.