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 6, 2026.
657of 657 medicine recallsshown with your filters
The list
- Medicine recall Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ Labeling: Not Elsewhere Classified; Product labeling contains the claim of ‘Paraben Free’ while the product does in fact contain parabens as part of the… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month… Class IIIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle Failed Impurities/Degradation Specifications Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Budesonide Extended-Release Tablets 9mg, 30-count bottle Failed Dissolution Specifications Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Budesonide Extended-Release Tablets, 9 mg, 30-count bottles Failed Dissolution Specifications Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedFeb 7, 2024ClassClass IIStatusTerminatedWhereIllinois
- Medicine recall FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Rifampin Capsules USP 150mg, 30-count bottle Subpotent Drug and Failed Impurities/Degradation Specifications Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2024ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Rifampin Capsules USP 300mg, 30-count bottle Subpotent Drug and Failed Impurities/Degradation Specifications Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2024ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Rifampin Capsules USP, 150 mg, 30 Capsules Failed Impurities/Degradation Specification. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall OralProCare medicated lip treatment CGMP Deviations: products may not conform to the labeled specifications. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl CGMP Deviations: products may not conform to the labeled specifications. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle Labeling: Label Mix-up FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Benzonatate Capsules, USP, 100 mg, 100 Capsules Superpotent drug: Assay results were slightly above specification at the time zero point. Class IIIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Vasopressin 2 Unit/2 mL Subpotent Drug Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedJan 31, 2024ClassClass IIStatusOngoingWhereMinnesota
- Medicine recall Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methoxsalen Capsules, USP 10mg, 50-count bottle Failed Dissolution Specifications Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial Presence of particulate matter: glass FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after… Lack of Sterility Assurance: Aseptic process simulation failure. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cinacalcet Tablets 60mg CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Febuxostat Tablets 40mg CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Febuxostat Tablets 80 mg CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Lurasidone Hydrochloride Tablets 60mg CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Lurasidone Hydrochloride Tablets 120mg CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Niacin Extended-Release Tablets, USP 1000mg CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Niacin Extended-Release Tablets, USP 500mg CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ Microbial Contamination of Non-Sterile Products FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ Microbial Contamination of Non-Sterile Products FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor… MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Vasostrict (vasopressin Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL Presence of Particulate Matter; identified as glass FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 24, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL Presence of Particulate Matter; identified as glass FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 24, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Atropine Sulfate Injection, USP 1 mg/10 mL Presence of Particulate Matter; identified as glass FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 24, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz Chemical Contamination: presence of benzene FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IStatusCompletedWhereNationwide
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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