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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 17,501–17,520 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass III

Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ

by Sandoz Incorporated

Reason
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Recall initiated
January 22, 2013
Reported by FDA
February 13, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YORK, N.Y. 10022 NDC 11559-008-01

by Estee Lauder Inc

Reason
Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.
Recall initiated
October 23, 2012
Reported by FDA
February 13, 2013
Distribution
Nationwide, Puerto Rico, Bermuda and Panama

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Drug Recall Terminated Historical recordClass II

Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

by West-Ward Pharmaceutical Corp.

Reason
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Recall initiated
December 7, 2012
Reported by FDA
February 13, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.

by West-Ward Pharmaceutical Corp.

Reason
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Recall initiated
December 5, 2012
Reported by FDA
February 13, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873

by Globe All Wellness, LLC

Reason
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
Recall initiated
September 20, 2012
Reported by FDA
February 13, 2013
Distribution
Nationwide and Puerto Rico and internationally to Barbados, Brazil, Canada, Cyprus, Equador, France, Germany, Israel, Mexico, and Netherlands.

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Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.

by Mylan Pharmaceuticals Inc.

Reason
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Recall initiated
January 30, 2013
Reported by FDA
February 13, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***

by Ascend Therapeutics Inc

Reason
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Recall initiated
November 19, 2012
Reported by FDA
February 13, 2013
Distribution
Products were distributed nationwide.

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Drug Recall Terminated Historical recordClass II

Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.

by Watson Pharmaceuticals

Reason
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Recall initiated
December 18, 2012
Reported by FDA
February 13, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90.

by Stat Rx USA

Reason
Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Recall initiated
January 28, 2013
Reported by FDA
February 13, 2013
Distribution
PA

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Drug Recall Terminated Historical recordClass III

Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.

by Actelion Pharmaceuticals U.S., Inc.

Reason
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Recall initiated
January 16, 2013
Reported by FDA
February 13, 2013
Distribution
CA & VA

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Drug Recall Terminated Historical recordClass III

Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738

by Warner Chilcott Company LLC

Reason
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Recall initiated
December 21, 2012
Reported by FDA
February 6, 2013
Distribution
US Nationwide

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Drug Recall Terminated Historical recordClass III

Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738

by Warner Chilcott Company LLC

Reason
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Recall initiated
December 21, 2012
Reported by FDA
February 6, 2013
Distribution
US Nationwide

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Drug Recall Terminated Historical recordClass II

HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03

by Hillyard GMP

Reason
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Recall initiated
December 28, 2012
Reported by FDA
February 6, 2013
Distribution
Distribution nationwide

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Drug Recall Terminated Historical recordClass II

Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033

by Schering-Plough Products, LLC

Reason
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Recall initiated
December 12, 2012
Reported by FDA
February 6, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.

by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Reason
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Recall initiated
December 6, 2012
Reported by FDA
February 6, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.

by Mylan Pharmaceuticals Inc.

Reason
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Recall initiated
January 16, 2013
Reported by FDA
February 6, 2013
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01.

by Belmora LLC

Reason
Defective Container: Product lacks tamper evident breakaway band on cap.
Recall initiated
December 18, 2012
Reported by FDA
January 30, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990.

by Genentech Inc

Reason
Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
Recall initiated
July 30, 2012
Reported by FDA
January 30, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03

by Axcentria Pharmaceuticals LLC

Reason
Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
Recall initiated
August 17, 2012
Reported by FDA
January 30, 2013
Distribution
MI

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Drug Recall Terminated Historical recordClass II

PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.

by West-Ward Pharmaceutical Corp.

Reason
Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
Recall initiated
December 5, 2012
Reported by FDA
January 30, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.