FDA Drug recall D-0395-2015
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, N…
- FDA Drug
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, N… by Actavis Elizabeth, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0395-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-10 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis Elizabeth |
| Distribution | US |
Product
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
Reason
Failed Dissolution Specifications
Identifiers
| upc | 345963305091 |
|---|---|
| ndc | 45963-303-09 |
| ndc | 45963-304-09 |
| ndc | 45963-305-09 |
| code_info | Lot #: 2020E141, Exp 07/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0395-2015%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.