FDA-Drug2026-07-01Class IIPROCESSING DEFECT
Ajanta Pharma fenofibrate capsules recalled for manufacturing quality deviations
What this means
Ajanta Pharma USA Inc. is recalling one lot of fenofibrate 200 mg capsules due to manufacturing quality deviations discovered during inspection. The affected lot (PA02216, expiring 12/2029) was distributed nationwide.
- Check your medication bottle for lot number PA02216 and expiration date 12/2029.
- Contact your pharmacy or doctor if you have this lot; do not stop taking fenofibrate without medical guidance.
- Return unused medication to your pharmacy for proper disposal.
The agency's original wording
Hazard
CGMP Deviations
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide
Affected count
3648 bottles
Manufactured in
400 Crossing Blvd Ste 102, N/A, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0611-2026Want us to check the next one for you?
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