Browse Drug Recalls

1,732 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,732 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 1,732 FDA drug recalls, Class I.

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DateProductReasonClassFirm
May 20, 2013 JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutram... Class I Dolphin Intertrade Corporation
May 20, 2013 XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutram... Class I Dolphin Intertrade Corporation
May 13, 2013 Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufa... Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who disc... Class I Zydus Pharmaceuticals USA Inc
May 13, 2013 Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as... Non-Sterility; contract laboratory identified Staphylococcus warneri in the product Class I Abrams Royal Pharmacy
May 10, 2013 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk ... Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon rec... Class I Apotex Corp.
May 6, 2013 Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89... Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA anal... Class I Chang Kwung Products
May 6, 2013 Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 8... Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA anal... Class I Chang Kwung Products
May 1, 2013 Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister pac... Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ... Class I Beamonstar Products
May 1, 2013 SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister pac... Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ... Class I Beamonstar Products
Apr 30, 2013 Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box,... Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... Class I American Lifestyle.Com
Apr 30, 2013 Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold l... Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... Class I American Lifestyle.Com
Apr 19, 2013 Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluro... Non-Sterility Class I Abrams Royal Pharmacy
Apr 15, 2013 HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVisio... Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assuranc... Class I NuVision Pharmacy, Inc.
Apr 15, 2013 Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVisio... Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assuranc... Class I NuVision Pharmacy, Inc.
Apr 10, 2013 Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pil... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil,... Class I Affirm XL, Inc.
Apr 1, 2013 ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomos... Class I Consumer Concepts, Inc.
Mar 29, 2013 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hos... Presence of Particulate Matter: reports of small grey/brown particles found in the primary contai... Class I Hospira Inc.
Mar 18, 2013 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk ... Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon rec... Class I Apotex Corp.
Mar 14, 2013 Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infu... Non-Sterility; mold contamination Class I Med Prep Consulting, Inc.
Mar 11, 2013 Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet ... Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil whi... Class I Green Planet Inc
Feb 12, 2013 MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 c... Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA dr... Class I OLAAX International
Jan 31, 2013 Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx on... Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir ... Class I Gilead Sciences, Inc.
Jan 25, 2013 Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container,... Non-Sterility: Confirmed customer complaint of product contaminated with mold. Class I Hospira Inc.
Jan 4, 2013 Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA,... Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingre... Class I Reumofan Plus USA
Jan 3, 2013 Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49... Non-Sterility: one or more components of the kit have been found to be contaminated with yeast. Class I Mobius Therapeutics LLC
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 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 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 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 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 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 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 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 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 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 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 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 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 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
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
Nov 21, 2012 Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66... Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Class I Bracco Diagnostic Inc
Nov 21, 2012 Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector S... Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Class I Bracco Diagnostic Inc
Nov 8, 2012 Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Steri... Crystallization: Product is being recalled due to visible particulates identified during a retain... Class I Hospira Inc.
Nov 8, 2012 Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Steri... Crystallization: Product is being recalled due to visible particulates identified during a retain... Class I Hospira Inc.
Oct 22, 2012 Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi... Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the... Class I Zi Xiu Tang Success, LLC
Oct 22, 2012 Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bot... Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the... Class I Zi Xiu Tang Success, LLC
Oct 5, 2012 Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers... Non-Sterility: One confirmed customer report that product contained spore-like particulates, cons... Class I Hospira Inc.
Sep 26, 2012 Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL an... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL a... Non-Sterility Class I New England Compounding Center

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.