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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 6,621–6,640 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Recall initiated
December 20, 2019
Reported by FDA
January 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.

by AVKARE Inc.

Reason
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Recall initiated
January 7, 2020
Reported by FDA
January 22, 2020
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ

by Sun Pharmaceutical Industries, Inc.

Reason
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Recall initiated
December 26, 2019
Reported by FDA
January 22, 2020
Distribution
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.

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Drug Recall Terminated Historical recordClass I

Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX

by Motto International Corp

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Recall initiated
December 17, 2019
Reported by FDA
January 22, 2020
Distribution
TX

View recall →

Drug Recall Terminated Historical recordClass III

SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

by Idelle Labs

Reason
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Recall initiated
November 20, 2019
Reported by FDA
January 15, 2020
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

by Idelle Labs

Reason
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Recall initiated
November 20, 2019
Reported by FDA
January 15, 2020
Distribution
Nationwide in the USA

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.