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Browse Drug Recalls

63 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 63 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 63 FDA drug recalls.

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DateProductReasonClassFirm
Mar 24, 2014 PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Ma... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 20, 2014 Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Ap... Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 mont... Class III Apotex Inc.
Jul 17, 2013 Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by A... Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitri... Class II Apotex Inc.
Jun 25, 2013 Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx o... Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), there... Class II Apotex Inc
May 10, 2013 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk ... Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon rec... Class I Apotex Corp.
Mar 18, 2013 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk ... Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon rec... Class I Apotex Corp.
Apr 5, 2012 Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured ... Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a ... Class II Apotex Corp.
Jun 15, 2011 Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metere... CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. Class III Apotex Corp.
Jun 14, 2007 Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apot... Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. Class II Apotex Corp.
Jun 14, 2007 Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-co... Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. Class II Apotex Corp.

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.