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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
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 23, 2026 at 11:04 PM UTC.
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