Food, drugs, devices › Impax Laboratories, Inc.
Drug recall: Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, N
Impax Laboratories, Inc. (Hayward, CA) initiated this drug recall on 17 Mar 2016; FDA lists 2 product records under event 73551, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 43% of the 288 drug enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 27 Oct 2016. Initiation: voluntary: firm initiated. Impax Laboratories, Inc. has 3 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Impax Laboratories, Inc., Hayward, CA.
Reason for recall
"Labeling: Incorrect or Missing Lot and/or Exp. Date"
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0820-2016 | Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02 | 28,001 HDPE bottles (14,000,500 capsules) | Class III | Terminated | 20 Apr 2016 |
| D-0821-2016 | Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02 | 42,239 HDPE bottles ( 21,119,500 capsules) | Class III | Terminated | 20 Apr 2016 |
Context
Other enforcement events for Impax Laboratories, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Aug 2016 | Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manu | Drug | Class I | 1 |
| 14 Mar 2016 | Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LL | Drug | Class II | 2 |
All 3 events for Impax Laboratories, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling: Incorrect or Missing Lot and/or Exp. Date"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Oct 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.