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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 13,821–13,840 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

View recall →

Drug Recall Terminated Historical recordClass II

Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Recall initiated
April 17, 2015
Reported by FDA
June 17, 2015
Distribution
United States Nationwide

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Drug Recall Terminated Historical recordClass III

Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06

by Sandoz, Inc

Reason
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Recall initiated
April 15, 2015
Reported by FDA
June 10, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.

by Fresenius Kabi USA, LLC

Reason
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Recall initiated
April 28, 2015
Reported by FDA
June 10, 2015
Distribution
US; Nationwide, including Puerto Rico

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Drug Recall Terminated Historical recordClass II

SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433

by Medtech Products, Inc.

Reason
Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.
Recall initiated
May 21, 2015
Reported by FDA
June 10, 2015
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications: OOS result during stability testing
Recall initiated
May 11, 2015
Reported by FDA
June 10, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.

by Mylan Lab Inc

Reason
Failed Dissolution Specifications: Low out of specification dissolution results.
Recall initiated
May 20, 2015
Reported by FDA
June 10, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02

by Blenheim Pharmacal, Inc.

Reason
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Recall initiated
May 22, 2015
Reported by FDA
June 3, 2015
Distribution
Indiana

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Drug Recall Terminated Historical recordClass II

Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02

by Blenheim Pharmacal, Inc.

Reason
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Recall initiated
May 22, 2015
Reported by FDA
June 3, 2015
Distribution
Indiana

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Drug Recall Terminated Historical recordClass I

LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.

by Hospira Inc.

Reason
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Recall initiated
March 11, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
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.