Fenofibrate Capsules — Class II drug recall D-0611-2026
Ongoing recall by Ajanta Pharma USA Inc, reported 2026-07-01, distributed nationwide. CGMP Deviations
| Recall number | D-0611-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ajanta Pharma USA Inc, Bridgewater, NJ, United States |
| Recall initiated | 2026-05-28 |
| Classified | 2026-06-22 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 3,648 bottles |
| Reason classes | cgmp |
| NDC | 27241-0118, 27241-0118-04, 27241-0118-05, 27241-0119, 27241-0119-04, 27241-0119-05, 27241-0120, 27241-0120-04, 27241-0120-05 |
| Lot numbers | PA02216 |
| Expiration dates | 2029-12 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0611-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.