Browse Drug Recalls

76 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 76 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 76 FDA drug recalls.

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DateProductReasonClassFirm
May 29, 2015 Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bo... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.
Apr 7, 2015 Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 6050... Subpotent drug Class III Apotex Inc.
Apr 7, 2015 Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 605... Subpotent drug Class III Apotex Inc.
Apr 7, 2015 Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, M... Subpotent drug Class III Apotex Inc.
Feb 12, 2015 Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, ... CGMP Deviations: Product excipient was not re-tested at the appropriate date. Class III Apotex Inc.
Oct 16, 2014 Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured b... Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... Class III Apotex Inc.
Oct 16, 2014 Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b... Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... Class III Apotex Inc.
Oct 16, 2014 Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b... Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... Class III Apotex Inc.
Oct 16, 2014 Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured b... Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... Class III Apotex Inc.
Apr 18, 2014 Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manu... Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. Class III Apotex Corp.
Mar 24, 2014 Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 PAXIL (Paroxetine HCL) Tablets 20 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) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
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
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.
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.