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 fentaNYL in dextrose 5%, 300 mcg/30 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 1,250 mcg/25 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall succinylcholine, 200 mg/10 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone in dextrose 5%, 3 mg/30 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone in dextrose 5%, 0.5 mg/5 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dr. Berne’s MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne’s Whole Health Products,… CGMP Deviations Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dr. Berne’s MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne’s Whole Health Products,… CGMP Deviations Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dr. Berne’s Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne’s Whole… CGMP Deviations Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dr. Berne’s MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne’s Whole Health Products,… CGMP Deviations Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dr. Berne’s MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne’s Whole Health Products,… Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets… Failed Dissolution Specifications Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. Class IIIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Epinephrine-Lidocaine HCl Subpotent: Failing Test Results for Epinephrine Class IIIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT). Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportVirginiathe one state its words name PublishedOct 4, 2023ClassClass IIStatusTerminatedWhereVirginia
- Medicine recall Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. Class IIIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%) Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging. Class IIIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall MAJOR LubriFresh P.M Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each Lack of Assurance of Sterility Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereColorado and Rhode Island
- Medicine recall BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile… Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep” Clear 1 mL Applicator cannot be substantiated beyond 12-months… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Rasagiline Tablets 0.5mg, 30-count bottle Failed dissolution specifications - results obtained were below spec average. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials Subpotent: Out of Specification result observed for low assay Class IIIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl… Incorrect/Undeclared Excipients. Class IIIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 27, 2023ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30 Subpotent Drug: Product does not contain SPF that is declared on the label. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30 Subpotent Drug: Product does not contain SPF that is declared on the label. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pantoprazole Sodium for Injection 40mg per vial, Single dose vials Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall WEFUN Capsules 825 mg, 1x10 blister pack per carton 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 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2023ClassClass IStatusTerminatedWhereNationwide
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.”
Your shortlist0 of 4
Add one more to compare.