Methylphenidate Hydrochloride — Class II drug recall D-0579-2024
Terminated recall by Trigen Laboratories, reported 2024-07-10, distributed nationwide. Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution sp
| Recall number | D-0579-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trigen Laboratories, Alpharetta, GA, United States |
| Recall initiated | 2024-06-17 |
| Classified | 2024-07-02 |
| Reported by FDA | 2024-07-10 |
| Terminated | 2025-09-23 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| 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 | 230159M |
| Expiration dates | 2026-02-28 |
Product
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
Reason for recall
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
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-0579-2024. 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.