Class II · ModerateRecall completed
AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberSE5019062-A
Where it was soldFL, GA, SC
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Cardinal Health Inc. |
Show the full FDA record
| Full product label | AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS |
| Recalling firm | Cardinal Health Inc. |
| Distribution | FL, GA, SC |
| Quantity | 373 bottles |
| Recall initiated | 2021-03-15 |
| Report date | 2021-06-02 |
| Recall completed | 2024-06-17 |
| Recall number | D-0439-2021 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Dublin OH United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.