FDA Drug recall D-0821-2016
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
- FDA Drug
- Class III
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class III recall of Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02 by Impax Laboratories, citing labeling: Incorrect or Missing Lot and/or Exp. Date.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0821-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-03-17 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Impax Laboratories |
| Distribution | US |
Product
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
Reason
Labeling: Incorrect or Missing Lot and/or Exp. Date
Identifiers
| code_info | Lot # 10008320; Exp. 05/16 Lot # 10008744, 10008974; Exp. 11/16 Lot # 10009342; Exp. 03/17 Lot # 10010202; Exp…Lot # 10008320; Exp. 05/16 Lot # 10008744, 10008974; Exp. 11/16 Lot # 10009342; Exp. 03/17 Lot # 10010202; Exp. 09/17 Lot # 20001416A; Exp. 10/17 Lot # 20001557A; Exp. 01/18 Lot # 20001675A; Exp. 03/18 Lot # 20001831A; Exp. 06/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class III · 2016-04-20 · Impax Laboratories
All Impax Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0821-2016%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.