FDA Drug recall D-0826-2016
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 088…
- FDA Drug
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 088… by Impax Laboratories, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0826-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-14 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Impax Laboratories |
| Distribution | US |
Product
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
Reason
Failed Impurities/Degradation Specifications
Identifiers
| code_info | Lot #: 112565, Exp 03/17; 113458, Exp 08/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Impax Laboratories
- Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson…
FDA Drug · Class I · 2016-12-28 · Impax Laboratories - Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08…
FDA Drug · Class II · 2016-04-27 · Impax Laboratories - 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 · 2016-04-20 · Impax Laboratories - Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
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-0826-2016%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.