FDA Drug recall D-1430-2015
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules
- FDA Drug
- Class III
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class III recall of Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules by Novartis Pharmaceuticals, citing failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1430-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-07-28 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novartis Pharmaceuticals |
| Distribution | NJ |
Product
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Reason
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Identifiers
| code_info | Lot #: F0002, Exp 12/2016 |
|---|
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-1430-2015%22
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