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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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Drug Recall Terminated Historical recordClass II

BUP 675MCG/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 5MG/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 5MG/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 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) 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 4MG/FENT 3000MCG/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 40MG/MORP 4MG/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 40MG/FENT 3000MCG/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 40MG/FENT 1200MCG/SUF 400MCG/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 3 mg/MORP 15 mg/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 3MG/HYDROM 15MG/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/FENT 1.5MG/ML 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 30MG/FENT 750MCG/HYDROM 15MG/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

BUP 30MG/ MORP 8MG/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 30MG/ HYDROM 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 30MG/ FENT 400MCG/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 3.5MG/ HYDROM 4MG/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 2MG/ HYDROM 2MG/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 23MG/HYDROM 25MG/SUF 100MCG/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/SUF 105MCG/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/SUF 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 →

Data last updated: September 17, 2026 ET

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.