Methylphenidate Hydrochloride Tablets USP — Class III drug recall D-0052-2018
Terminated recall by Teva Pharmaceuticals USA, reported 2017-11-01, distributed nationwide. Failed Dissolution Specifications: Low out of specification results for dissolution.
| Recall number | D-0052-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2017-10-17 |
| Classified | 2017-10-26 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2018-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 58,292 bottles |
| Reason classes | specification failure |
| NDC | 00591-5884-01 |
| Lot numbers | 08/18, 1156086M |
Product
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
Reason for recall
Failed Dissolution Specifications: Low out of specification results for dissolution.
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-0052-2018. 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.