Medicines, 2023
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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 Ganciclovir for Injection, USP, 500mg per vial Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg. Class IIFDA’s classJan 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 4, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets Failed impurities/degradation specifications: Out of specification for unknown impurities. Class IIFDA’s classJan 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 4, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits. Class IIFDA’s classJan 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 4, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life. Class IIIFDA’s classJan 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 4, 2023ClassClass IIIStatusTerminatedWhereNationwide
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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.
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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