Methylphenidate Hydrochloride Extended-Release Capsules — Class II drug recall D-847-2013
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2013-08-14, distributed nationwide. Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results o
| Recall number | D-847-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2013-06-18 |
| Classified | 2013-08-07 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 16,293 bottles |
| Reason classes | specification failure |
| NDC | 00093-5346-01 |
Product
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
Reason for recall
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-847-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.