The Recall Desk
ModerateFDA (Drugs)·D-0439-2021·Announced 2021-06-02

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.

What this means for you

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
Hazard
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

Distributed in 3 states:

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.

See all 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

See all →

Same hazard · temperature excursion

See all →