Browse Drug Recalls

2,021 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,021 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 2,021 FDA drug recalls.

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DateProductReasonClassFirm
Oct 10, 2014 Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by ... Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were pac... Class II Contract Packaging Resources Inc.
Oct 7, 2014 ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ... Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listin... Class II Zee Medical Products Inc
Oct 3, 2014 Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-... Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as... Class II Sagent Pharmaceuticals Inc
Sep 12, 2014 Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, R... Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled roo... Class II Mckesson
Sep 8, 2014 Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq... Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride inject... Class II Baxter Healthcare Corp
Aug 28, 2014 Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingr... Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not b... Class II Solace International Inc
Aug 28, 2014 Dermatend Original, mole, wart and skin tag remover, For external use only, I... Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not b... Class II Solace International 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 7, 2014 MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana. Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... Class II New Gpc Inc.
Aug 7, 2014 alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product p... Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... Class II New Gpc Inc.
Aug 7, 2014 alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a p... Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... Class II New Gpc Inc.
Aug 7, 2014 Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. ... Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... Class II New Gpc Inc.
Aug 7, 2014 Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A... Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due t... Class II New Gpc Inc.
Aug 7, 2014 WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm... Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... Class II New Gpc Inc.
Aug 7, 2014 Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic ... Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... Class II New Gpc Inc.
Aug 6, 2014 Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white spr... Microbial Contamination of Non-Sterile Product Class II HLI dba Humphreyline 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 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 1, 2014 Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Pa... Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... Class I American Health Packaging
Jul 1, 2014 Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Pac... Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... Class I American Health Packaging
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 12, 2014 Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bo... Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary suppleme... Class II Thorne Research Inc
Jun 12, 2014 Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles... Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary suppleme... Class II Thorne Research 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
Jun 2, 2014 Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808 Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked i... Class II Unit Dose Solutions Inc
Jun 2, 2014 Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only... Presence of Particulate Matter: Product failed the appearance for the presence of visible particl... Class I Alexion Pharmaceuticals, Inc.
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 16, 2014 ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syring... Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine ... Class II US Compounding Inc
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 29, 2014 Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes d... Class II Flawless Beauty LLC
Apr 29, 2014 Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates ... Class II Flawless Beauty LLC
Apr 29, 2014 Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable ... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates ... Class II Flawless Beauty LLC
Apr 29, 2014 Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes d... Class II Flawless Beauty LLC
Apr 29, 2014 Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 1... Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. Class II Flawless Beauty LLC
Apr 29, 2014 Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules... Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling... Class II Flawless Beauty LLC
Apr 21, 2014 Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx ... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 17, 2014 Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trig... Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 mic... Class III Trigen Laboratories, Inc.
Apr 15, 2014 Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl an... Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. Class III P&L Developments, LLC
Apr 14, 2014 Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorph... Subpotent Drug: Phenylephrine component is subpotent. Class III P&L Developments, LLC
Apr 14, 2014 Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufacture... Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the p... Class III Upsher Smith Laboratories, Inc.
Apr 11, 2014 Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dex... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Apr 9, 2014 Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10)... Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Rele... Class II Legacy Pharmaceutical Packaging
Apr 4, 2014 Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laborator... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... Class III Boehringer Ingelheim Roxane Inc
Apr 4, 2014 Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laborato... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... Class III Boehringer Ingelheim Roxane Inc
Apr 1, 2014 HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (4... Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown... Class II Hi-Tech Pharmacal Co., Inc.
Apr 1, 2014 PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Kon... Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. Class III Konsyl Pharmaceuticals 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.