Class II · ModerateActive recall
Fenofibrate
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # PA02216; Exp. 12/2029
Where it was soldU.S. 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
CGMP Deviations
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
Made byAjanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807 foreign manufacturer
| Brand name | FENOFIBRATE |
| Generic name | FENOFIBRATE |
| Active ingredient(s) | FENOFIBRATE |
| Distributed by / for | Ajanta Pharma USA Inc |
| NDC | 27241-120-04 |
Show the full FDA record
| Full product label | Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04. |
| Recalling firm | Ajanta Pharma USA Inc |
| Distribution | U.S. Nationwide |
| Quantity | 3648 bottles |
| Recall initiated | 2026-05-28 |
| Report date | 2026-07-01 |
| Recall completed | — |
| Recall number | D-0611-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Bridgewater NJ 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.