Browse Drug Recalls

534 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 534 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 534 FDA drug recalls in 2012.

Clear
DateProductReasonClassFirm
Dec 28, 2012 Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, M... Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for ... Class I Advance Pharmaceutical Inc
Dec 28, 2012 HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride ... Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria. Class II Hillyard GMP
Dec 27, 2012 Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tub... Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which ... Class III Ranbaxy Inc.
Dec 27, 2012 Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only... Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which ... Class III Ranbaxy Inc.
Dec 22, 2012 Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules ... Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenaf... Class I D& S Herbals, LLC
Dec 21, 2012 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 m... Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeli... Class II Lee Pharmaceuticals, Inc
Dec 21, 2012 Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactur... Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles Class III Warner Chilcott Company LLC
Dec 21, 2012 Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactu... Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles Class III Warner Chilcott Company LLC
Dec 19, 2012 SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19... Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are ... Class I P & J Trading Co
Dec 18, 2012 Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl... Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia ce... Class I Matrixx Initiatives Inc
Dec 18, 2012 Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 36... Failed Dissolution Specification: Out of a specification result occurred during the 3-month stabi... Class II Watson Pharmaceuticals
Dec 18, 2012 Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting... Defective Container: Product lacks tamper evident breakaway band on cap. Class III Belmora LLC
Dec 17, 2012 libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1,... Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... Class I Performance Plus Marketing, Inc.
Dec 17, 2012 EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13... Subpotent; bupivacaine Class II Pacira Pharmaceuticals, Inc.
Dec 17, 2012 libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count bliste... Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... Class I Performance Plus Marketing, Inc.
Dec 17, 2012 Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 4... Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of th... Class II L. Perrigo Co.
Dec 17, 2012 Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 co... Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... Class I Performance Plus Marketing, Inc.
Dec 17, 2012 CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister ... Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... Class I Performance Plus Marketing, Inc.
Dec 17, 2012 Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister... Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... Class I Performance Plus Marketing, Inc.
Dec 17, 2012 BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count bliste... Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... Class I Performance Plus Marketing, Inc.
Dec 17, 2012 BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual E... Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... Class I Performance Plus Marketing, Inc.
Dec 14, 2012 Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tabl... Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both... Class I Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Dec 13, 2012 Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen)... Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities. Class III Watson Laboratories Inc
Dec 12, 2012 Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringe... Impurities/Degradation Products: Out of Specification results found for impurity B, identified as... Class III Boehringer Ingelheim Roxane Inc
Dec 12, 2012 Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, Fo... Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-spec... Class II Schering-Plough Products, LLC
Dec 10, 2012 Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity... Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded ... Class III Upsher Smith Laboratories, Inc.
Dec 10, 2012 WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: H... Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Ente... Class I Brower Enterprises Inc
Dec 7, 2012 Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottl... Presence of Foreign Substance: Uncharacteristic blacks spots on tablets. Class II West-ward Pharmaceutical Corp.
Dec 7, 2012 Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifen... Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from t... Class III Bayer Healthcare, LLC
Dec 7, 2012 Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bo... Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tab... Class II West-ward Pharmaceutical Corp.
Dec 7, 2012 Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (N... Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant ... Class II West-ward Pharmaceutical Corp.
Dec 6, 2012 Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged... Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. Class I Vintage Pharmaceuticals LLC DBA Qualitest Pharm...
Dec 5, 2012 PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (... Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the t... Class II West-ward Pharmaceutical Corp.
Dec 5, 2012 PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (... Presence of Foreign Substance: A complaint was received for black specks identified as stainless ... Class II West-ward Pharmaceutical Corp.
Dec 5, 2012 Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single us... Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of p... Class II Teva Pharmaceuticals USA, Inc.
Dec 5, 2012 Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165... Failed impurities/degradation specifications: Purity readings for oxygen were out of specification. Class II Oklahoma Respiratory Care Inc
Dec 4, 2012 Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-... Failed Dissolution Specifications; 36 month stability timepoint Class II West-ward Pharmaceutical Corp.
Dec 4, 2012 Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per b... Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contain... Class II Abbott Laboratories
Dec 4, 2012 Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Via... Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on t... Class I Green Valley Drugs
Dec 4, 2012 Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on... Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut... Class II Amedra Pharmaceuticals LLC
Dec 4, 2012 Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on... Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut... Class II Amedra Pharmaceuticals LLC
Dec 4, 2012 Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on... Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut... Class II Amedra Pharmaceuticals LLC
Dec 4, 2012 Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC,... Superpotent (Single Ingredient Drug): salicylic acid Class III Johnson & Johnson
Dec 4, 2012 Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green ... Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on t... Class I Green Valley Drugs
Nov 30, 2012 Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-c... Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel parti... Class II West-ward Pharmaceutical Corp.
Nov 30, 2012 VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 617... Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored. Class II West-ward Pharmaceutical Corp.
Nov 30, 2012 Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, M... Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Regist... Class III West-ward Pharmaceutical Corp.
Nov 29, 2012 NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for ... Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological sp... Class II Mariposa Labs, LLC
Nov 26, 2012 TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packa... Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the di... Class III Pfizer Inc.
Nov 21, 2012 Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only... Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a mis... Class II Hospira, 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.