D-0611-2026Class II

Ajanta Pharma USA Inc

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2026-07-01

Distribution

U.S. Nationwide

Firm state

Product quantity

3648 bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

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.

Code / lot info

Lot # PA02216; Exp. 12/2029

Other recalls SPEQ maps to Risk Management & CAPA

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See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.