FDA Drug recall D-0579-2024
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC,…
- FDA Drug
- Class II
- terminated
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC,… by Trigen Laboratories, citing failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0579-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-06-17 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Trigen Laboratories |
| Distribution | US |
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
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Identifiers
| ndc | 13811-709-10 |
|---|---|
| ndc | 13811-706-10 |
| ndc | 13811-707-10 |
| ndc | 13811-708-10 |
| ndc | 13811-710-10 |
| ndc | 13811-710-30 |
| code_info | Lot 230159M, Exp Date 2/28/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0579-2024%22
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