Medicines, 2023
Shortlist up to four to read them side by side.
1,252 medicine recalls FDA’s Enforcement Report published in 2023, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
1,252of 1,252 medicine recallsshown with your filters
The list
- Medicine recall Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Microplegia Solution, MSA/MSG 0.92 Molar with CP2D Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Transplant Solution (Plasma-Lyte A) Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, del Nido Formula Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Maintenance 4:1 in Ringer’s, low potassium, 12 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Induction 4:1 in Ringer’s, HIGH POTASSIUM, 48 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Microplegia Solution, HIGH POTASSIUM Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, LEESBURG CARDIOPLEGIA Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Modified del Nido Microplegia Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with low calcium and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low calcium and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with low calcium and HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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