Why it was recalled
CGMP Deviations
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.
Lot numbers, UPCs & expiration codes
Lot # PA02216; Exp. 12/2029
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0611-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 28, 2026
- FDA report date
- Jul 1, 2026
- Quantity
- 3648 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ajanta Pharma USA Inc
Original FDA data
Every field from FDA enforcement report D-0611-2026, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99130
- Address
- 400 Crossing Blvd Ste 102
- Code information
- Lot # PA02216; Exp. 12/2029
- Postal code
- 08807-2863
- Report date
- Jul 1, 2026
- Product type
- Drugs
- Recall number
- D-0611-2026
- Classification
- Class II
- Recalling firm
- Ajanta Pharma USA Inc
- Product quantity
- 3648 bottles
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- May 28, 2026
- Center classification date
- Jun 22, 2026