Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Dexmethylphenidate HCl Extended-Release Recalled by Novartis Pharmaceuticals Corp. Due to Failed Dissolution Specifications: Product is being recalled due...

Date: July 28, 2015
Company: Novartis Pharmaceuticals Corp.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Novartis Pharmaceuticals Corp. directly.

Affected Products

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

Quantity: 10,767 bottles

Why Was This 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.

Where Was This Sold?

This product was distributed to 1 state: NJ

Affected (1 state)Not affected

About Novartis Pharmaceuticals Corp.

Novartis Pharmaceuticals Corp. has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report