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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

HYDROMORPHONE 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

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Drug Recall Terminated Historical recordClass II

HYDROMORPHONE 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

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Drug Recall Terminated Historical recordClass II

HYDROM 10MG/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

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Drug Recall Terminated Historical recordClass II

HCG 10,000U/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

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Drug Recall Terminated Historical recordClass II

HCG 1,000U/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

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Drug Recall Terminated Historical recordClass II

FENTANYL 800MCG/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

FENTANYL 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

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Drug Recall Terminated Historical recordClass II

FENTANYL 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

View recall →

Drug Recall Terminated Historical recordClass II

FENTANYL 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

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Drug Recall Terminated Historical recordClass II

FENTANYL 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

FENT 900MCG/SUF 210MCG/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

FENT 600MCG/ SUF 800MCG/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

CLON 800MCG/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

CLON 750MCG/MORP 30MG/SUF 37.5MCG/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

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Drug Recall Terminated Historical recordClass II

CLON 500MCG/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

CLON 300MCG/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

CLON 100MCG/MORP 12MG/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

CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 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

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Drug Recall Terminated Historical recordClass II

BUP 8MG/CLON 100MCG/HYDROM 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 7MG/HYDROM 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 →

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.