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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 15,001–15,020 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass III

Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Recall initiated
June 19, 2014
Reported by FDA
September 3, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.

by Alkermes, Inc.

Reason
Customer complaints for failure to deliver the dose.
Recall initiated
March 4, 2014
Reported by FDA
September 3, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.

by Novel Laboratories, Inc.

Reason
Failed Impurity/Degradation Specification; 12-month stability time point
Recall initiated
June 20, 2014
Reported by FDA
September 3, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04

by Healix Infusion Therapy, Inc.

Reason
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Recall initiated
June 27, 2014
Reported by FDA
August 27, 2014
Distribution
Texas and Georgia

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Drug Recall Terminated Historical recordClass II

fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-33

by Healix Infusion Therapy, Inc.

Reason
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Recall initiated
June 27, 2014
Reported by FDA
August 27, 2014
Distribution
Texas and Georgia

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02

by Healix Infusion Therapy, Inc.

Reason
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Recall initiated
June 27, 2014
Reported by FDA
August 27, 2014
Distribution
Texas and Georgia

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8002-04

by Healix Infusion Therapy, Inc.

Reason
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Recall initiated
June 27, 2014
Reported by FDA
August 27, 2014
Distribution
Texas and Georgia

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-90

by Healix Infusion Therapy, Inc.

Reason
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Recall initiated
June 27, 2014
Reported by FDA
August 27, 2014
Distribution
Texas and Georgia

View recall →

Drug Recall Terminated Historical recordClass I

0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
Recall initiated
May 12, 2014
Reported by FDA
August 27, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673

by Doctor's Best, Inc.

Reason
Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
Recall initiated
June 24, 2014
Reported by FDA
August 27, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588

by US Compounding Inc

Reason
Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.
Recall initiated
May 16, 2014
Reported by FDA
August 27, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30

by Hospira Inc.

Reason
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Recall initiated
April 2, 2014
Reported by FDA
August 27, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.

by Pharmacy Creations

Reason
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Recall initiated
June 25, 2014
Reported by FDA
August 27, 2014
Distribution
NY, NJ, and Puerto Rico

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Drug Recall Terminated Historical recordClass II

PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01

by Fresenius Kabi USA, LLC

Reason
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
Recall initiated
August 13, 2014
Reported by FDA
August 27, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2.

by Trigen Laboratories, Inc.

Reason
Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
Recall initiated
April 17, 2014
Reported by FDA
August 27, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01

by Ben Venue Laboratories Inc

Reason
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Recall initiated
July 31, 2014
Reported by FDA
August 27, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.

by Baxter Healthcare Corp

Reason
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Recall initiated
August 4, 2014
Reported by FDA
August 27, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA

by Wockhardt Usa Inc.

Reason
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Recall initiated
July 24, 2014
Reported by FDA
August 27, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02

by Hospira Inc.

Reason
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Recall initiated
January 10, 2014
Reported by FDA
August 27, 2014
Distribution
Nationwide and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Recall initiated
June 20, 2014
Reported by FDA
August 27, 2014
Distribution
U.S. 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.