Browse Drug Recalls

1,702 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,702 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 1,702 FDA drug recalls, Class III.

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DateProductReasonClassFirm
Mar 10, 2015 AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen... Failed Impurities/Degradation Specification; out of specification results for carbon dioxide Class III Matheson, Inc.
Feb 27, 2015 Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Ma... Subpotent Drug Class III AVKARE Inc.
Feb 27, 2015 Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Man... Subpotent Drug Class III AVKARE Inc.
Feb 26, 2015 Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufac... Failed Impurities/Degradation Specifications Class III Pfizer Inc.
Feb 26, 2015 Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manuf... Failed Impurities/Degradation Specifications Class III Pfizer Inc.
Feb 16, 2015 Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5... Failed Impurities/Degradation Specifications; 12 month stability testing. Class III West-Ward Pharmaceutical Corporation
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.
Feb 12, 2015 Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane,... Labeling: Illegible label. Writing is rubbing off of labels. Class III Nanophase Technologies Corporation
Feb 11, 2015 DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use... Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may... Class III Mylan Institutional LLC
Jan 23, 2015 Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dos... Subpotent Drug and Failed Impurities/Degradation Specifications Class III Mylan Institutional LLC
Jan 8, 2015 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-08... Subpotent Drug Class III Freedom Pharmaceuticals Inc
Dec 26, 2014 Deferoxamine various strengths in normal saline Lack of sterility assurance. Class III Walgreens Infusion Services
Dec 22, 2014 ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL,... Failed Impurities/Degradation Specifications: High out of specification results for the known imp... Class III Qualitest Pharmaceuticals
Dec 19, 2014 3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tub... Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number a... Class III 3M Company/3m Espe Dental Products
Dec 9, 2014 sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids... Failed pH specification: Product pH test value of 5.72 failed to meet its product specification o... Class III J. Strickland and Co
Dec 9, 2014 Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size:... Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 ... Class III Akorn, Inc.
Dec 5, 2014 Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sand... Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an i... Class III Sandoz Incorporated
Dec 5, 2014 BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactur... Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or ill... Class III Eisai Inc
Dec 4, 2014 Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (1... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the C... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: M... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Dec 4, 2014 Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline H... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-c... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Dec 4, 2014 Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: M... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Nov 25, 2014 Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx... Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when st... Class III Hospira Inc.
Nov 10, 2014 Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-releas... Defective container: A customer complaint revealed the presence of a defective seal on the top of... Class III Reckitt Benckiser LLC
Nov 7, 2014 Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g... Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another ... Class III Hospira Inc.
Oct 24, 2014 Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, Car... Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to h... Class III CareFusion 213, LLC
Oct 21, 2014 Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufact... Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was err... Class III Taro Pharmaceuticals U.S.A., Inc.
Oct 20, 2014 Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane,... cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lo... Class III Nanophase Technologies Corporation
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.
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, 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, 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 10, 2014 MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and D... Subpotent; 6 month stability time point Class III American Health Packaging
Oct 10, 2014 TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL an... Crystallization: Impurities in a raw material used to manufacture the diluent can cause the forma... Class III Pfizer Inc.
Oct 2, 2014 Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, M... Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... Class III Valeant Pharmaceuticals International
Oct 2, 2014 candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactur... Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated ... Class III Sandoz, Inc
Oct 2, 2014 Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufacture... Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... Class III Valeant Pharmaceuticals International
Oct 1, 2014 Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manuf... Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344. Class III Zydus Pharmaceuticals USA Inc
Sep 30, 2014 Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) table... Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates. Class III Gilead Sciences, Inc.
Sep 24, 2014 BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured... Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsu... Class III Zydus Pharmaceuticals USA Inc
Sep 18, 2014 E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -c... Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months. Class III Bracco Diagnostic Inc
Sep 11, 2014 MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21)... Subpotent; 6 month stability time point Class III Qualitest Pharmaceuticals
Aug 25, 2014 Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, ... Failed Content Uniformity Specifications. Class III Taro Pharmaceuticals U.S.A., Inc.
Aug 21, 2014 Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count... Failed Impurity/Degradation Specification; high out of specification for CAD II degradant Class III Apotex Corp.
Aug 20, 2014 CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeu... Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG. Class III ChiroNutraceutical LLC
Aug 19, 2014 Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: ... Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy ... Class III Micro Labs Usa, Inc ...
Aug 19, 2014 Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. ... Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution te... Class III Perrigo Holland 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.