Methylphenidate Hydrochloride Extended-release Tablets — Class III drug recall D-0581-2018
Terminated recall by Osmotica Pharmaceutical Corp, reported 2018-03-14, distributed nationwide. Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27
| Recall number | D-0581-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Osmotica Pharmaceutical Corp, Marietta, GA, United States |
| Recall initiated | 2018-02-28 |
| Classified | 2018-03-06 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2019-05-01 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 13811-0706, 13811-0706-10, 13811-0707, 13811-0707-10, 13811-0708, 13811-0708-10, 13811-0709, 13811-0709-10, 13811-0710, 13811-0710-10, 13811-0710-30 |
| Lot numbers | 170231B, 170232A, 170233A, 170234A |
Product
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Reason for recall
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
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-0581-2018. 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.