US Drug Recall Register
Class III · Low risk Terminated Initiated Jul 28, 2015 (11 years ago)

Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.

What was recalled

Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540

Recalling firm
Novartis Pharmaceuticals Corp.
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1430-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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