Medicines, 2019
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2,152 medicine recalls FDA’s Enforcement Report published in 2019, 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.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b)… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b)… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b)… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection Defective Delivery System: difficult to express Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For… Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5% Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. Class IIIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5% Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. Class IIIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dexmedetomidine 400 mcg in NS 100 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Clindamycin 900 mg in NS 50 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Diltiazem 250 mg in NS 250 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Labetalol 20 mg/4 mL, 20 mg Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Magnesium Sulfate 1 GM in NS 50 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Magnesium Sulfate 2 GM in NS 50 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Magnesium Sulfate 4 GM in NS 50 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Magnesium Sulfate 6 GM in NS 50 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall NICARdipine 25 mg in NS 250 mL EXCEL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Norepinephrine 16 mg in NS 250 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Oxytocin 30 units in NS 500 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Alteplase 1 mg/mL 1 mL Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall CeFAZolin 1 GM a) in NS 100 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall CeFAZolin 2 GM a) in NS 100 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall CeFAZolin 3 gm 100 mg/mL, 30 mL syringe Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Chlorothiazide 100 mg, 3.57 mL syringe Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Heparin Pork 30,000 Units in NS 1000 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Phenylephrine 0.8 mg/10 mL NS Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Phenylephrine 20 mg NS 250 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Phenylephrine 40 mg Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Sodium Bicarbonate 150 mEq in D5W 1000 mL bags Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Vancomycin 1000 mg in NS 250 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Vancomycin 1250 mg in NS 250 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Vancomycin 1500 mg in NS 250 mL bag Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Vancomycin 1750 mg Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Vancomycin 2000 mg Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium… Lack of sterility assurance. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Fentanyl Citrate Injection, USP, 100 mcg/2 mL Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing. Class IIIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 3.125 mg, 500-count bottle Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product,… Class IIIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles Failed Impurities/Degradation Specifications Class IIIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles Failed Impurities/Degradation Specifications Class IIIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles Failed Impurities/Degradation Specifications Class IIIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles Failed Impurities/Degradation Specifications Class IIIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Extended-Release Tablets, 200 mg Failed Impurities/Degradation Specifications Class IIIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIIStatusTerminatedWhereNationwide
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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