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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 10,841–10,860 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

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Drug Recall Terminated Historical recordClass II

FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

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Drug Recall Terminated Historical recordClass II

FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only, 10 mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel

by Teva Pharmaceuticals USA

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
April 24, 2017
Reported by FDA
May 17, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01

by Sanofi-Aventis U.S. LLC

Reason
Labeling: Incorrect or Missing Package Insert
Recall initiated
September 1, 2016
Reported by FDA
May 17, 2017
Distribution
Nattionwide

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Drug Recall Terminated Historical recordClass III

PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87

by Teva Pharmaceuticals USA

Reason
Failed Stability Specifications
Recall initiated
March 28, 2017
Reported by FDA
May 17, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.

by Sun Pharmaceutical Industries, Inc.

Reason
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Recall initiated
March 22, 2017
Reported by FDA
May 17, 2017
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18.

by Sun Pharmaceutical Industries, Inc.

Reason
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Recall initiated
March 22, 2017
Reported by FDA
May 17, 2017
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.

by Sun Pharmaceutical Industries, Inc.

Reason
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Recall initiated
March 22, 2017
Reported by FDA
May 17, 2017
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.

by Sun Pharmaceutical Industries, Inc.

Reason
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Recall initiated
March 22, 2017
Reported by FDA
May 17, 2017
Distribution
Nationwide in the USA and Puerto Rico

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.