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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 14,501–14,520 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04

by Baxter Healthcare Corp

Reason
Lack of Assurance of Sterility; increased complaints received for leaks
Recall initiated
March 23, 2015
Reported by FDA
April 8, 2015
Distribution
Nationwide and Singapore

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Drug Recall Terminated Historical recordClass II

Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27

by American Specialty Pharmacy

Reason
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Recall initiated
December 12, 2014
Reported by FDA
April 1, 2015
Distribution
TX

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Drug Recall Terminated Historical recordClass II

5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04

by Baxter Healthcare Corp.

Reason
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Recall initiated
March 18, 2015
Reported by FDA
April 1, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03

by Baxter Healthcare Corp.

Reason
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Recall initiated
March 18, 2015
Reported by FDA
April 1, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.

by Bethel Nutritional Consulting, Inc

Reason
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
Recall initiated
December 19, 2014
Reported by FDA
April 1, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder, NDC: 55037-302-18, 55037-302-19, 55037-302-20.

by Matheson, Inc.

Reason
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
Recall initiated
March 10, 2015
Reported by FDA
April 1, 2015
Distribution
Michigan and Wisconsin

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Drug Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

by Mylan Institutional LLC

Reason
Lack of Assurance of Sterility; due to leaking vials
Recall initiated
February 18, 2015
Reported by FDA
April 1, 2015
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

by Mylan Institutional LLC

Reason
Lack of Assurance of Sterility; due to leaking vials
Recall initiated
February 18, 2015
Reported by FDA
April 1, 2015
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.

by West-Ward Pharmaceutical Corporation

Reason
Failed Impurities/Degradation Specifications; 12 month stability testing.
Recall initiated
February 16, 2015
Reported by FDA
April 1, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02, UPC 3 11917 15114 4.

by Tarmac Products, Inc.

Reason
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Recall initiated
February 6, 2015
Reported by FDA
March 25, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Recall initiated
March 5, 2015
Reported by FDA
March 25, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31

by Heritage Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Recall initiated
February 25, 2015
Reported by FDA
March 25, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31

by Heritage Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Recall initiated
February 25, 2015
Reported by FDA
March 25, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01

by Mutual Pharmaceutical Company, Inc.

Reason
Failed Impurities/Degradation Specifications: during long-term stability testing.
Recall initiated
March 10, 2015
Reported by FDA
March 25, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10

by Mylan Institutional LLC

Reason
Subpotent Drug and Failed Impurities/Degradation Specifications
Recall initiated
January 23, 2015
Reported by FDA
March 25, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01.

by Mylan Institutional LLC

Reason
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
Recall initiated
February 11, 2015
Reported by FDA
March 25, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.

by Qualitest Pharmaceuticals

Reason
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Recall initiated
February 23, 2015
Reported by FDA
March 18, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.

by Fusion Pharmaceuticals, LLC

Reason
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Recall initiated
March 6, 2015
Reported by FDA
March 18, 2015
Distribution
California

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Drug Recall Terminated Historical recordClass III

Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.

by Micro Labs Usa, Inc S

Reason
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Recall initiated
December 4, 2014
Reported by FDA
March 18, 2015
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass III

Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.

by Micro Labs Usa, Inc S

Reason
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Recall initiated
December 4, 2014
Reported by FDA
March 18, 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.