Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 15,401–15,420 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass III

Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75

by Pinnacle Biologics Inc

Reason
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Recall initiated
February 10, 2014
Reported by FDA
March 19, 2014
Distribution
US: Nationwide and Taiwan

View recall →

Drug Recall Terminated Historical recordClass I

Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy, P.C.

Reason
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
Recall initiated
October 19, 2013
Reported by FDA
March 19, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass III

Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
Failed Impurity/degradation Specification
Recall initiated
January 28, 2014
Reported by FDA
March 19, 2014
Distribution
US: Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095.

by CTV Best Group

Reason
Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug.
Recall initiated
August 1, 2013
Reported by FDA
March 19, 2014
Distribution
Nationwide and Australia, Canada.

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50

by Actavis Elizabeth LLC

Reason
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
Recall initiated
February 10, 2014
Reported by FDA
March 19, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.

by Fougera Pharmaceuticals Inc.

Reason
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Recall initiated
January 29, 2014
Reported by FDA
March 19, 2014
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass I

METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL

by Mira Health Products Ltd.

Reason
Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
Recall initiated
July 22, 2013
Reported by FDA
March 12, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433.

by Mira Health Products Ltd.

Reason
Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
Recall initiated
July 22, 2013
Reported by FDA
March 12, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735

by Mira Health Products Ltd.

Reason
Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug
Recall initiated
July 22, 2013
Reported by FDA
March 12, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.

by Fresenius Kabi USA, LLC

Reason
Subpotent; 18 month time point
Recall initiated
January 22, 2014
Reported by FDA
March 12, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02

by Hospira Inc.

Reason
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Recall initiated
February 10, 2014
Reported by FDA
March 12, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716 f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895

by Dr. Reddy's Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.
Recall initiated
January 3, 2014
Reported by FDA
March 12, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Voriconazole 0.5mg/ml

by Natures Pharmacy & Compounding Center

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 1, 2013
Reported by FDA
March 12, 2014
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Voriconazole 0.5mg/ml

by Natures Pharmacy & Compounding Center

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 1, 2013
Reported by FDA
March 12, 2014
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Voriconazole 1% opthal

by Natures Pharmacy & Compounding Center

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 1, 2013
Reported by FDA
March 12, 2014
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Vitamin D (Ergocalciferol) 800 u/ml

by Natures Pharmacy & Compounding Center

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 1, 2013
Reported by FDA
March 12, 2014
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Vit A (olive oil) 0.1% opth.

by Natures Pharmacy & Compounding Center

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 1, 2013
Reported by FDA
March 12, 2014
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin (fortified) 25mg/ml opth

by Natures Pharmacy & Compounding Center

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 1, 2013
Reported by FDA
March 12, 2014
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Triamcinolone Acetonide 3mg/ml

by Natures Pharmacy & Compounding Center

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 1, 2013
Reported by FDA
March 12, 2014
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 200mg/ml

by Natures Pharmacy & Compounding Center

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 1, 2013
Reported by FDA
March 12, 2014
Distribution
NC

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.