FDA recall D-0611-2026

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 for recall

CGMP Deviations

Distribution

U.S. Nationwide

Key facts

Status

Ongoing

Initiation date

2026-05-28

Report date

2026-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0611-2026