Fenofibrate Capsules — Class III drug recall D-0821-2016
Terminated recall by Impax Laboratories, Inc., reported 2016-04-20, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp. Date
| Recall number | D-0821-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Impax Laboratories, Inc., Hayward, CA, United States |
| Recall initiated | 2016-03-17 |
| Classified | 2016-04-14 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-10-27 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 00115-0533-02 |
| Lot numbers | 01/18, 03/17, 03/18, 05/16, 06/18, 09/17, 10/17, 10008320, 10008744, 10008974, 10009342, 10010202, 11/16, 20001416A, 20001557A, 20001675A, 20001831A |
Product
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp. Date
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-0821-2016. 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.