FDA Drug recall D-849-2013
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
- FDA Drug
- Class II
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class II recall of Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01 by Teva Pharmaceuticals Usa, citing failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-849-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-18 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
Reason
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Identifiers
| ndc | 0093-5346-01 |
|---|---|
| ndc | 0093-5347-01 |
| ndc | 0093-5348-01 |
| code_info | 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14. |
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-849-2013%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.