Cardinal Health Recalls Amoxicillin Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 373 bottles of Amoxicillin 500mg tablets due to intermittent exposure to temperature excursions during storage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible health consequences. The hazard is a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
Cardinal Health Inc. is recalling 373 bottles of Amoxicillin 500mg tablets (NDC/UPC 65862001401) due to deviations from Current Good Manufacturing Practices (CGMP). The recall is caused by intermittent exposure to temperature excursions during the storage of the product.
The affected product is identified by the code SE5019062-A. The recall covers distribution in Florida, Georgia, and South Carolina. The agency has classified this recall as Class II.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or obtain a replacement. Do not use the product if you have concerns about its stability due to the reported temperature issues.
The recalled product
- Product
- AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Antibiotic
- Affected units
- 373
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- SE5019062-A
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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