FDAClass II · Drug · Recalled July 1, 2026

Fenofibrate Capsules recall — Ajanta Pharma USA Inc

Hazard: CGMP Deviations

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0611-2026
Brand: Ajanta Pharma USA
Classification: Class II
Units affected: 3648 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

Fenofibrate Capsules

Companies & origin

Recalling firm location: Bridgewater, NJ, United States
Firm address: 400 Crossing Blvd Ste 102, N/A, 08807-2863

Identifying details (verbatim from the notice)

Product codes / lots: Lot # PA02216; Exp. 12/2029
Distribution: U.S. Nationwide
Firm notified the public via: N/A
FDA event ID: 99130
Recall initiated: May 28, 2026
FDA classified: June 22, 2026
FDA report date: July 1, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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