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 BD-102 NF, Microcrystalline Cellulose, NF, Ph Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class IIIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle Sub-Potent Drug: Out of specification for assay at the 24 month interval. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Gabapentin Tablets, USP 600 mg, 500 tablets per bottle Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles. Class IIIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Diltiazem HCl Lack of Assurance of Sterility Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine Bitartrate Lack of Assurance of Sterility Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine Bitartrate Lack of Assurance of Sterility Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine Bitartrate Lack of Assurance of Sterility Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP, 1 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP, 0.4 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP, 0.8 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Lack of Assurance of Sterility Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free Subpotent Drug Class IIIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials CGMP Deviations: Potential product carryover. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Aripiprazole Tablets, USP 2 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Aripiprazole Tablets, USP 5 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Aripiprazole Tablets, USP 10 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Aripiprazole Tablets, USP 15 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Aripiprazole Tablets, USP 20 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Aripiprazole Tablets, USP 30 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Atorvastatin Calcium Tablets USP, 10 mg* CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Atorvastatin Calcium Tablets USP 20 mg* CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Atorvastatin Calcium Tablets USP 40 mg* CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Atorvastatin Calcium Tablets USP 80 mg* CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall BusPIRone Hydrochloride Tablets USP, 5 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall BusPIRone Hydrochloride Tablets USP 15 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Clopidogrel Tablets USP, 75 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Daptomycin for Injection 350 mg/vial CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Daptomycin for Injection 500 mg per vial, Single-dose vial CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Dofetilide Capsules, 125 mcg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Dofetilide Capsules 250 mcg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Dofetilide Capsules 500 mcg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Doxazosin Tablets USP 1 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Doxazosin Tablets USP, 2 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Doxazosin Tablets USP, 4 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Doxazosin Tablets USP, 8 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Finasteride Tablets USP, 1 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Finasteride Tablets USP 1 mg, 90-count bottle, Keeps CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Finasteride Tablets USP, 5 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Glimepiride Tablets USP, 1 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Glimepiride Tablets USP, 2 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Glimepiride Tablets USP, 4 mg CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Glycopyrrolate Injection, USP, 0.4 mg/2 mL CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Glycopyrrolate Injection, USP 1 mg/5 mL CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Glycopyrrolate Injection, USP 4 mg/20 mL CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 8, 2023ClassClass IIStatusTerminatedWherePuerto Rico
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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