FDAClass IIJuly 1, 2026

Fenofibrate Capsules recall: CGMP Deviations

Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc.…

Why was Fenofibrate Capsules recalled?

CGMP Deviations

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # PA02216; Exp. 12/2029

Product
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc.…
Recalling firm
Ajanta Pharma USA Inc
Quantity
3648 bottles
Distribution
U.S. Nationwide
Recall date
July 1, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls