Browse Drug Recalls

1,720 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,720 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 1,720 FDA drug recalls, Class III.

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DateProductReasonClassFirm
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
Aug 5, 2014 Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass... Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl im... Class III Akorn, Inc.
Jul 30, 2014 Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL... Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval a... Class III Pfizer Inc.
Jul 30, 2014 Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, M... Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making... Class III Novartis Pharmaceuticals Corp.
Jul 28, 2014 OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx onl... Failed Stability Specifications: Out of specification result for preservative sodium benzoate. Class III Boehringer Ingelheim Roxane Inc
Jul 17, 2014 Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, ... Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each m... Class III X-Gen Pharmaceuticals Inc.
Jul 14, 2014 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, R... Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzo... Class III Wockhardt Usa Inc.
Jul 11, 2014 Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (... Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... Class III Sandoz Inc
Jul 8, 2014 VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only... Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect ex... Class III Pfizer Inc.
Jul 3, 2014 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermat... Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet s... Class III Fougera Pharmaceuticals Inc.
Jul 3, 2014 Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules... Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jul 3, 2014 Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatol... Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet s... Class III Fougera Pharmaceuticals Inc.
Jul 2, 2014 E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manu... Subpotent Drug: Low out of specification results for both pH and assay obtained during routine st... Class III Bracco Diagnostic Inc
Jun 26, 2014 LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guai... Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, an... Class III Poly Pharmaceuticals, Inc
Jun 26, 2014 POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Ma... Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, an... Class III Poly Pharmaceuticals, Inc
Jun 20, 2014 Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint F... Failed Impurity/Degradation Specification; 12-month stability time point Class III Novel Laboratories, Inc.
Jun 20, 2014 Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharma... Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. Class III Mylan Pharmaceuticals Inc.
Jun 19, 2014 Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. ... Failed Dissolution Specification; at the 12 month time interval. Class III Mckesson Packaging Services
Jun 19, 2014 Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottl... Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications f... Class III Pfizer Inc.
Jun 19, 2014 Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx on... Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... Class III Mylan Pharmaceuticals Inc.
Jun 17, 2014 Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.... Failed Impurities/Degradation Specifications: out of specification impurity test results. Class III Teva Pharmaceuticals USA
Jun 17, 2014 Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyc... Failed Impurities/Degradation Specifications: out of specification impurity test results. Class III Teva Pharmaceuticals USA
Jun 17, 2014 Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 ... Failed Impurities/Degradation Specifications: out of specification impurity test results. Class III Teva Pharmaceuticals USA
Jun 17, 2014 Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15... Failed Impurities/Degradation Specifications: out of specification impurity test results. Class III Teva Pharmaceuticals USA
Jun 6, 2014 DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorop... Stability Data Does Not Support Expiry Class III Estee Lauder Inc
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-co... Labeling: Incorrect or Missing Package Insert Class III Valeant Pharmaceuticals North America LLC
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-co... Labeling: Incorrect or Missing Package Insert Class III Valeant Pharmaceuticals North America LLC
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count... Labeling: Incorrect or Missing Package Insert Class III Valeant Pharmaceuticals North America LLC
May 28, 2014 Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule... Failed Stability Specification; out of specification result for particle size distribution during... Class III Novartis Pharmaceuticals Corp.
May 21, 2014 Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-... Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... Class III Valeant Pharmaceuticals North America LLC
May 21, 2014 Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmac... Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... Class III Valeant Pharmaceuticals North America LLC
May 14, 2014 Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distribu... Labeling: Missing Label; The label on the immediate bottle is missing. Class III Oasis Medical Inc
Apr 25, 2014 PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg an... Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Class III Prestige Brands Holdings

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.