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Browse Drug Recalls

379 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 379 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 379 FDA drug recalls in N/A.

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DateProductReasonClassFirm
Oct 15, 2015 Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel c... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bo... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF ... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Aug 25, 2015 Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-... Lack of Assurance of Sterility: Failed preservative effectiveness testing Class II Apotex Inc.
Aug 5, 2015 Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd ... Failed Impurities/Degradation Specifications: Out of specification results for impurities testing... Class III Taro Pharmaceuticals, Inc.
Jul 13, 2015 Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by P... Subpotent drug Class III Perrigo Israel Pharmaceuticals
May 29, 2015 Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.
May 29, 2015 Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufacture... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.
May 29, 2015 Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufacture... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.
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 24, 2015 Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Ma... Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Class III Cipla Limited
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.
Jan 21, 2015 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distr... Presence of Particulate Matter: lot is not meeting the specification limit for number of particle... Class II Sun Pharma Global Fze
Jan 21, 2015 Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Ma... Failed Dissolution Specifications: 6 month time point. Class II Sun Pharma Global Fze
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.
Sep 26, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles... Failed Dissolution Specifications; 12 month stability time point Class II Sun Pharma Global Inc.
Apr 8, 2014 Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfi... Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discover... Class II Pfizer Inc.
Feb 14, 2014 etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 m... Presence of Particulate Matter: Potential for small black particles to be present in individual v... Class II Agila Specialties Private Ltd.
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
Sep 5, 2012 Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (rec... Lack of Assurance of Sterility; container closure issues with the bulk batch. Class II F. Hoffmann-LaRoche Ltd.
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.
Mar 9, 2012 Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX... Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir ... Class II Aurobindo Pharma LTD

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.