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 Montelukast Sodium 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 Phenylephrine Hydrochloride Injection, USP 10 mg/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 Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL 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 Phenylephrine Hydrochloride Injection, USP 100 mg/10 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 Rosuvastatin 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 Rosuvastatin 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 Rosuvastatin 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 Rosuvastatin 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 Simvastatin 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 Simvastatin 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 Simvastatin 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 Simvastatin 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 Simvastatin 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 Succinylcholine Chloride Injection, USP, 200 mg/10 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 Tadalafil Tablets, USP, 2.5 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 Tadalafil 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 Tadalafil 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 Tadalafil 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 Vigabatrin for Oral Solution, USP, 500 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 Pirfenidone Tablets 267 mg 90-count bottle x3/Carton 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 Pirfenidone Tablets 801 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 Pravastatin Sodium 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 Pravastatin Sodium 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 Pravastatin Sodium 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 Pravastatin Sodium 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 rOPINIRole Tablets USP 0.25 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 rOPINIRole Tablets USP 0.5 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 rOPINIRole Tablets USP 1 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 rOPINIRole Tablets USP 2 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 rOPINIRole Tablets USP 3 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 rOPINIRole Tablets USP 4 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 rOPINIRole Tablets USP 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 Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton Packaging defect: observed packaging defect, blister packaging inadequately sealed. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%)… Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. Class IIIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules. Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL Subpotent Drug Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 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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