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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 14,481–14,500 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recall initiated
December 17, 2014
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recall initiated
December 17, 2014
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recall initiated
December 17, 2014
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recall initiated
December 17, 2014
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recall initiated
December 17, 2014
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recall initiated
December 17, 2014
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recall initiated
December 17, 2014
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recall initiated
December 17, 2014
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box. each container is lined with a polystyrene insert; CAPS, Allentown, PA

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recall initiated
December 17, 2014
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01

by RemedyRePack Inc.

Reason
Crystallization
Recall initiated
February 18, 2015
Reported by FDA
April 15, 2015
Distribution
PA, OK.

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Drug Recall Terminated Historical recordClass II

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

by Hospira Inc.

Reason
Crystallization
Recall initiated
January 23, 2015
Reported by FDA
April 15, 2015
Distribution
U.S. Nationwide and International: Guam and Singapore.

View recall →

Drug Recall Terminated Historical recordClass II

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

by Hospira Inc.

Reason
Crystallization
Recall initiated
January 23, 2015
Reported by FDA
April 15, 2015
Distribution
U.S. Nationwide and International: Guam and Singapore.

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Drug Recall Terminated Historical recordClass II

GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.

by Heritage Pharmaceuticals, Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Recall initiated
March 25, 2015
Reported by FDA
April 15, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA.

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Recall initiated
March 11, 2015
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.

by Wallcur Incorporated

Reason
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Recall initiated
January 6, 2015
Reported by FDA
April 15, 2015
Distribution
United States including Puerto Rico; and Canada

View recall →

Drug Recall Terminated Historical recordClass I

MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).

by Hospira Inc.

Reason
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Recall initiated
December 3, 2014
Reported by FDA
April 15, 2015
Distribution
US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.

View recall →

Drug Recall Terminated Historical recordClass II

Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84

by Navinta LLC

Reason
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Recall initiated
March 9, 2015
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.

by Qualitest Pharmaceuticals

Reason
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Recall initiated
March 25, 2015
Reported by FDA
April 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)

by American Health Packaging

Reason
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Recall initiated
January 6, 2015
Reported by FDA
April 8, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31

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

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.