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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 2,781–2,800 of 18,047 drug recalls

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 →

Drug Recall Terminated Historical recordClass II

Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0001-1.

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 Ongoing Historical recordClass II

VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50

by Apollo Care, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 2, 2023
Reported by FDA
May 24, 2023
Distribution
Missouri only

View recall →

Drug Recall Ongoing Historical recordClass II

VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50

by Apollo Care, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 2, 2023
Reported by FDA
May 24, 2023
Distribution
Missouri only

View recall →

Drug Recall Ongoing Historical recordClass II

VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50

by Apollo Care, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 2, 2023
Reported by FDA
May 24, 2023
Distribution
Missouri only

View recall →

Drug Recall Ongoing Historical recordClass II

VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25

by Apollo Care, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 2, 2023
Reported by FDA
May 24, 2023
Distribution
Missouri only

View recall →

Drug Recall Ongoing Historical recordClass II

Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25

by Apollo Care, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 2, 2023
Reported by FDA
May 24, 2023
Distribution
Missouri only

View recall →

Drug Recall Ongoing Historical recordClass II

VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50

by Apollo Care, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 2, 2023
Reported by FDA
May 24, 2023
Distribution
Missouri only

View recall →

Drug Recall Ongoing Historical recordClass II

FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25

by Apollo Care, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 2, 2023
Reported by FDA
May 24, 2023
Distribution
Missouri only

View recall →

Drug Recall Ongoing Historical recordClass II

Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05

by Apollo Care, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 2, 2023
Reported by FDA
May 24, 2023
Distribution
Missouri only

View recall →

Drug Recall Ongoing Historical recordClass II

PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10

by Apollo Care, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 2, 2023
Reported by FDA
May 24, 2023
Distribution
Missouri only

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.

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