D-0611-2026 Class II Ongoing
FDA drug recall D-0611-2026 was initiated by Ajanta Pharma USA Inc on May 28, 2026 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing. Affected quantity: 3648 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2026
- Initiation Date
- May 28, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3648 bottles
Product Description
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.
Reason for Recall
CGMP Deviations
Distribution Pattern
U.S. Nationwide
Code Information
Lot # PA02216; Exp. 12/2029