Medicines, 2024
Shortlist up to four to read them side by side.
657 medicine recalls FDA’s Enforcement Report published in 2024, 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.
657of 657 medicine recallsshown with your filters
The list
- Medicine recall Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IStatusTerminatedWhereNationwide
- Medicine recall First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as “mineral oil , petrolatum “. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medicine recall Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 16, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 16, 2024ClassClass IStatusOngoingWhereNo state named
- Medicine recall Atorvastatin Calcium Tablets, USP, 40mg Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40… Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes Defective Container: Firm received complaints of broken tube at the seal. Class IIIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Hard Steel Capsules Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Gold Hard Steel Plus Liquid, 2 FL OZ bottles Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial Presence of Particulate Matter: Presence of glass particle. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240… Defective Delivery System: The dip tube is clogged causing the spray not to work. Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pluvicto, 1000 MBq/mL CGMP deviations Class IIFDA’s classOct 9, 2024in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereFlorida, Massachusetts, New Jersey, New York, Pennsylvania and Virginia
- Medicine recall Mupirocin Ointment, USP, 2%, 22 g Subpotent Drug Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle Temperature abuse: Products exposed to improper temperature above drug label specifications. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 2, 2024ClassClass IIStatusTerminatedWhereMaryland and Virginia
- Medicine recall Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) Microbial Contamination of Non-Sterile Product Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only Lack of Assurance of Sterility Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Refresh LACRI-LUBE Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Infla-650 Herbal Dietary Supplement, 700mg Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and North Carolina, Ohio and South Carolina named
- Medicine recall EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL CGMP deviations Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNorth Carolina
- Medicine recall Mycophenolic Acid Delayed-Release Tablets USP, 360 mg Failed Dissolution Specifications Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled Discoloration Class IIIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall BARRIER THERAPY SKIN PROTECTANT CREAM Microbial contamination of non-sterile Products - Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor LABELING: LABEL MIX-UP. Class IIIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Heparin (Heparin Sodium Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Semaglutide, 2 mL Lack of Assurance of Sterility Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tirzepatide 2 mL Lack of Assurance of Sterility Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SEMAGLUTIDE 5mg/2mL Lack of Assurance of Sterility Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SEMAGLUTIDE 10mg/4mL Lack of Assurance of Sterility Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX… Lack of Assurance of Sterility Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TIRZEPATIDE 20 mg/2mL Lack of Assurance of Sterility Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TIRZEPATIDE 60 mg/3mL Lack of Assurance of Sterility Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Indomethacin Extended-Release Capsules, USP, 75 mg Failed Dissolution Specifications: below specification results Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall IBU Ibuprofen Tablets, USP, 800 mg Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall IBU Ibuprofen Tablets, USP, 600 mg Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall IBU Ibuprofen Tablets, USP, 400 mg Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr Failed Impurities/Degradation Specifications - at 18-month Stability testing Class IIFDA’s classSep 4, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereCalifornia and Nevada
- Medicine recall Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen Injection, 1,000 mg per 100 mL Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 28, 2024ClassClass IStatusOngoingWhereOhio and Puerto Rico
- Medicine recall Lidocaine HCl Injection, 2% Lack of Assurance of Sterility Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets Superpotent Drug Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, E8000, 1000mL container Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Rubbing Alcohol CGMP Deviations: sterile water not used for production Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall HAND-I-SAN, No-Rinse Hand Sanitizer CGMP Deviations: sterile water not used for production Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count… Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 28, 2024ClassClass IStatusOngoingWhereNew Jersey, New York and Pennsylvania
- Medicine recall Timolol Maleate Ophthalmic Solution USP, 0.5% Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles Defective container; yellow colored spike from cap lodged in the nozzle Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the… Class IIIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 21, 2024ClassClass IIIStatusCompletedWhereNo state named
- Medicine recall Sevelamer Carbonate for Oral Suspension 0.8g packets Labeling: Incorrect or Missing Lot and/or Exp Date. Class IIIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets Marketed without Approved NDA/ANDA. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IStatusOngoingWhereNationwide
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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