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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.