FDA Drug recall D-0611-2026
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc
- FDA Drug
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc by Ajanta Pharma Usa, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0611-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-28 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ajanta Pharma Usa |
| Distribution | US |
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
CGMP Deviations
Identifiers
| ndc | 27241-118-04 |
|---|---|
| ndc | 27241-118-05 |
| ndc | 27241-119-04 |
| ndc | 27241-119-05 |
| ndc | 27241-120-04 |
| ndc | 27241-120-05 |
| code_info | Lot # PA02216; Exp. 12/2029 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0611-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.