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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 2,261–2,280 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0108-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0205-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0214-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0210-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0204-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0007-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0106-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0423-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0408-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 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.