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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 16,761–16,780 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass III

Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-807-30)

by Stayma Consulting Service, LLC.

Reason
Subpotent; Beta carotene (Vitamin A)
Recall initiated
June 28, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Manufactured for Eckson Labs, Wilmington, DE

by Stayma Consulting Service, LLC.

Reason
Subpotent; Beta carotene (Vitamin A)
Recall initiated
June 28, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc,. Batavia, IL 60510; UPC 0 4198 1525 8.

by Showline Automotive Products, Inc. dba US Soaps Mfg. Company

Reason
Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.
Recall initiated
August 6, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01

by American Health Packaging

Reason
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Recall initiated
February 4, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

(No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789

by Total Resources Intl

Reason
CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.
Recall initiated
April 9, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources International, Walnut, CA 91789

by Total Resources Intl

Reason
CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.
Recall initiated
April 9, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789

by Total Resources Intl

Reason
CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.
Recall initiated
April 9, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.

by Hi-Tech Pharmacal Co., Inc.

Reason
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
Recall initiated
July 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33

by Hospira Inc.

Reason
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Recall initiated
May 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887

by Sanofi-Synthelabo

Reason
Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
Recall initiated
February 26, 2013
Reported by FDA
August 21, 2013
Distribution
Canada

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Drug Recall Terminated Historical recordClass II

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40

by Bracco Diagnostics Inc

Reason
Presence of foreign substance: One lot of the product may contain black foreign particles
Recall initiated
June 21, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottlle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34

by Dr. Reddy's Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Recall initiated
August 2, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.

by West-Ward Pharmaceutical Corp.

Reason
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
Recall initiated
July 30, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20

by Boehringer Ingelheim Roxane Inc

Reason
Labeling: Missing Label; missing label on blister card
Recall initiated
June 14, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

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.