Class IITerminated

Methylphenidate Hydrochloride recall

FDA recall D-0579-2024 · initiated Jun 17, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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
Recalling company: Trigen Laboratories
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Jun 17, 2024
FDA report date: Jul 10, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0579-2024 ↗

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