Impax Laboratories, Inc.
Impax Laboratories, Inc. has 3 FDA enforcement events on this register (5 product records) between 2016 and 2016: 3 drug; the busiest year was 2016 with 3.
33% of its events are Class I; the most common class is Class I (1). 0 events are listed as ongoing; the recalling firm's address is in CA and NJ.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 19 Aug 2016 | Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA | Drug | Class I | 1 | Terminated |
| 17 Mar 2016 | Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02 | Drug | Class III | 2 | Terminated |
| 14 Mar 2016 | Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10 | Drug | Class II | 2 | Terminated |
By type and class
Class I: 33% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Impax Laboratories, Inc. had?
3 enforcement events (5 product records) on this register, 2016–2016: 3 drug.
Are any Impax Laboratories, Inc. recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Impax Laboratories, Inc. recalls?
1 Class I, 1 Class II, 1 Class III. 33% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.