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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 20MG/CLON 300MCG/FENT 2000MCG/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

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Drug Recall Terminated Historical recordClass II

BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/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 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/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

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Drug Recall Terminated Historical recordClass II

BUP 1MG//ML/HYDROM 7MG 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

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Drug Recall Terminated Historical recordClass II

BUP 17MG/MORP 22MG/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

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Drug Recall Terminated Historical recordClass II

BUP 15MG/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 15MG/CLON 600MCG/MORP 30MG/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 15MG/CLON 400MCG/ FENT 6000MCG/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 15MG/CLON 300MCG/ FENT 1500MCG/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 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/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

BPC-157 2000 mcg/mL in 5 mL vials 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

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Drug Recall Terminated Historical recordClass II

Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials 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

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Drug Recall Terminated Historical recordClass II

Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials 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 50MCG/ 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

BAC 400MCG/BUP 20MG/HYDROM 15MG/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 →

Drug Recall Terminated Historical recordClass II

BAC 4000MCG /FENT 600MCG/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 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML 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 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML 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 200MCG/ CLONI 250MCG/ 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

BAC 15MCG/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 →

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.