Class I · Most seriousRecall completed
Atovaquone Oral Suspension USP
A reasonable chance it could cause serious harm or death.
Does this affect you?
Check your lot numberLot: AW0221A Exp. 08/30/2025
Where it was soldUS Nationwide.
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
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
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 | AvKARE, Pulaski, TN 38478 |
| NDC | 50268-086-12 |
Show the full FDA record
| Full product label | Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12. |
| Recalling firm | AvKARE |
| Distribution | US Nationwide. |
| Quantity | 153 cartons |
| Recall initiated | 2024-03-28 |
| Report date | 2024-04-24 |
| Recall completed | 2024-08-23 |
| Recall number | D-0444-2024 |
| Classification | Class I |
| FDA status | Terminated |
| Origin on file | Pulaski TN 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.