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 Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%) 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 CBD Therapy 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
- Medicine recall Helix CBD Clinical 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
- Medicine recall Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705… Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range. Class IIIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle Subpotent: Out of Specification for Assay Test at the 3-month time point. Class IIIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Blis-To-Sol Liquid (Tolnaftate), 1% CGMP Deviations: Products not manufactured under current good manufacturing practices. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall YAGER’S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively CGMP Deviations: Products not manufactured under current good manufacturing practices. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively CGMP Deviations: Products not manufactured under current good manufacturing practices. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) CGMP Deviations: Products not manufactured under current good manufacturing practices. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate CGMP Deviations: Products not manufactured under current good manufacturing practices. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials CGMP Deviations: Products not manufactured under current good manufacturing practices. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Lugol’s (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single… CGMP Deviations: Products not manufactured under current good manufacturing practices. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Bendamustine HCl Injection, 100mg/4mL Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial. Class IIIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIIStatusCompletedWhereNationwide
- Medicine recall All Over-The-Counter (OTC) drug products warehoused, salvaged, and CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding. Lack of Assurance of Sterility Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding. Lack of Assurance of Sterility Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were… Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PLUVICTO 1,000MBq/mL Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date Class IIIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle Failed Impurities/Degradation Specifications Class IIIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Dofetilide Capsules 500 mcg Out of Specification result observed in content uniformity testing Class IIIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed. Class IIIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 16, 2023ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton CGMP deviation: product released prior to supplier approval. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall rocuronium50 mg/5 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall succinylcholine 200 mg/10 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall dilTIAZem 125mg/125mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall glycopyrrolate 1 mg/5 mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall dilTIAZem 125mg/125mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE… Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine 1,000 mcg/10mL Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall oxyTOCIN 10 units added to Lactated Ringer’s 500 mL, IV Bag Lack of assurance of sterility. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 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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