Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10

FDA recall notice · announced July 10, 2024 · Trigen Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot 230159M, Exp Date 2/28/2026
Quantity: 10,448 100-count bottles
Status: Terminated
Products in this recall event:
- Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10 (D-0579-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.