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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

SUFENTANIL 150MCG/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

QUADMIX FORTE in 1 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

QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 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

QUADMIX in 1 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

PHENOL 2.5% STERILE SOLUTION in 50 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

MORPHINE 7MG/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

MORPHINE 6MG/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

MORPHINE 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

MORPHINE 4MG/ML INJ in 20mL 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

MORPHINE 30MG/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

MORPHINE 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

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Drug Recall Terminated Historical recordClass II

MORPHINE 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

MORPHINE 18MG/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

MORPHINE 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

MORPHINE 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

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Drug Recall Terminated Historical recordClass II

MORP 20MG/SUF 70MCG/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 6MG/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

HYDROMORPHONE 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

HYDROMORPHONE 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

HYDROMORPHONE 3MG/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.