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 5, 2026.
1,252of 1,252 medicine recallsshown with your filters
The list
- Medicine recall CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer’s, High Potassium, IV Bag, total volume = 522.8 mL,… Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume… Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central… Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION 122 mEq K, Modified St Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central… Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer’s Low Potassium, IV Bag, total volume = 504.8 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume =… Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in dextrose 5%, 300 mcg/30 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 1250 mcg/25 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 100 mcg/2 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 250 mcg/5 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 2500 mcg/50 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vecuronium, 10 mg/10mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone in dextrose 5%, 3 mg/30 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 2500 mcg/50 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 5000 mcg/100 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture… Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture… Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall succinylcholine, 200 mg/10 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture… Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture… Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture… Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 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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