Ajanta Pharma USA Inc: Fenofibrate Capsules, Usp 200 Mg
Fenofibrate Capsules Recall Summary Ajanta Pharma USA Inc is recalling Fenofibrate Capsules, USP 200 mg (NDC 27241-120-04) distributed nationwide due to manufacturing process deviations that don't meet FDA standards. The recall affects 100-capsule bottles of this prescription medication used to treat high cholesterol. This is a Class II recall, meaning the product could cause adverse health effects, though serious injury is not likely.
- Recalling firm
- Ajanta Pharma USA Inc
- Product
- 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
- CGMP Deviations
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-28
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/b0a40a47-a76e-4d92-9e84-8f7f967f6ac6