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Browse Drug Recalls

515 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 515 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 515 FDA drug recalls.

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DateProductReasonClassFirm
Aug 3, 2012 Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patien... Presence of Particulate Matter: A single visible particulate was observed and confirmed in a samp... Class II Hospira Inc.
Jul 30, 2012 Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20... Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials ... Class I Genentech Inc
Jul 24, 2012 OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single... Presence of Particulate Matter: The firm initiated the recall due to visible presence of particul... Class II Cadence Pharmaceuticals
Jul 5, 2012 Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, M... Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline... Class II Ben Venue Laboratories Inc
Jun 26, 2012 Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg... Presence of Particulate Matter Class I Ben Venue Laboratories Inc
Apr 30, 2012 Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL... Presence of Particulate Matter: Lots identified in this recall notification may contain small pa... Class II Apotex Inc.
Apr 24, 2012 Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and I... Presence of Particulate Matter Class II Luitpold Pharmaceuticals, Inc.
Apr 13, 2012 Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 m... Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... Class II West-ward Pharmaceutical Corp.
Apr 13, 2012 Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10... Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... Class II West-ward Pharmaceutical Corp.
Apr 11, 2012 Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 U... Presence of Particulate Matter: A single visible particulate was observed in a retention sample b... Class II Hospira, Inc.
Feb 20, 2012 PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEV... Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. Class II Physicians Total Care, Inc.
Feb 20, 2012 PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEV... Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. Class II Physicians Total Care, Inc.
Dec 2, 2011 Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion O... A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a s... Class I Eagle Pharmaceuticals Inc.
Mar 15, 2011 CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL... Presence of Particulate Matter: In the course of inspecting retention samples visual particles w... Class II Luitpold Pharmaceuticals, Inc.
Oct 4, 2010 Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen In... Presence of Particulate Matter: glass delamination Class II Physicians Total 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.