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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 2,661–2,680 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0202-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0107-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0106-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0105-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0104-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0103-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0102-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0100-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0014-2.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0008-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0007-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0002-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
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.