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 Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets Failed dissolution specifications: below specification results at stability 12-month Class IIIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Milrinone Lactate Injection, USP 20mg/20 mL Failed Impurities/Degradation Specifications Class IIIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 13, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Tennessee named
- Medicine recall Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability. Class IIIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning… Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of… Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 13, 2023ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 13, 2023ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Digoxin Tablets, USP 0.125mg, 100-count bottles Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Digoxin Tablets, USP 0.25mg, 100-count bottles Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg… Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall rocuronium 50 mg/5 mL Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume =… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag,… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume =… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine 1,000 mcg/10mL Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine added to dextrose 5%, 4mg/250ml Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall oxyTOCIN 30 units added to Lactated Ringer’s 500 mL, IV Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall heparin added to 0.9% sodium chloride, 2500 units/500mL Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall dilTIAZem 125mg/125mL Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall dilTIAZem 125mg/125mL Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle Defective Container: slow leakage under the cap Class IIIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DIANEAL Low Calcium Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull… Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets Cross contamination with other products Class IIIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIIStatusCompletedWhereNationwide
- Medicine recall Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int’l) Corp Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Rufinamide Tablets, USP 200 mg cGMP deviations: Batch was released prior to approval. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rufinamide Tablets, USP 400 mg cGMP deviations: Batch was released prior to approval. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%) CGMP Deviations Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Helix Pain Relieving Cream (Menthol 7.4%) CGMP Deviations Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusTerminatedWhereNationwide
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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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