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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 2,421–2,440 of 18,047 drug recalls

Drug Recall Terminated Historical recordClass II

PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1

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

PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.

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

PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.

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

EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1.

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

EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.

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 del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Approx. Osmolarity 386 mOsm/L, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1

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

vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1

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

EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.

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

dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1

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

glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1

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

dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1

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

vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1

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

succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2.

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

rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.

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 I

Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA

by Lupin Pharmaceuticals Inc.

Reason
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Recall initiated
June 23, 2023
Reported by FDA
August 9, 2023
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4

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

fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1

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

PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1

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

midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1

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

lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1

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 →

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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