Safety Alerts & Recalls

What does this mean?

The FDA has not identified any serious safety concerns with the two generic methylphenidate hydrochloride extended-release products from Mallinckrodt and Kudco. There is the concern that the Mallinckrodt and Kudco products may release more slowly in the body and may result in patients not have the desired benefit from the medication. That said, if you or someone you care for takes a methylphenidate product, please continue to take your medication as directed, especially if it is working for you. You should not make changes to your treatment without first speaking with your healthcare provider.

If you or your healthcare provider are concerned that your methylphenidate product is not providing the desired effect, you may wish to check your prescription label to determine the manufacturer. If you do not know the manufacturer of your medicine, contact the pharmacy where the prescription was filled to verify the product’s manufacturer. If you or someone under your care are taking the Mallinckrodt or Kudco products and have concerns about lack of desired effect, contact your prescribing healthcare provider to discuss whether or not a different medication or brand would be more appropriate.

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website:

FDA Raises Concern About Generic Extended-Release Methylphenidate Hydrochloride Tablets (generic Concerta) made by Mallinckrodt and Kudco

The US Food and Drug Administration (FDA) has announced that it has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets) work as well as the brand-name medication for some patients. Methylphenidate hydrochloride extended-release tablets are used to treat attention-deficit hyperactivity disorder (ADHD) in adults and children. Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd make the two approved generic versions of Concerta that concern the FDA.

The FDA conducted a review of adverse event reports, previously submitted data, and FDA laboratory tests of methylphenidate hydrochloride extended-release products manufactured by Mallinckrodt and Kudco. These products are intended to release the medication in the body over a period of 10 to 12 hours. The FDA review found that, in some individuals, the Mallinckrodt and Kudco products may deliver the medication in the body at a slower rate during the 7- to 12-hour range. The slower release rate may result in some patients not having the desired effect.

As a result of the findings, the FDA has changed the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco methylphenidate hydrochloride extended-release products from AB to BX. This means the Mallinckrodt and Kudco products are still approved and can be prescribed, but are no longer considered generically equivalent to Concerta. These products are no longer recommended as automatically substitutable at the pharmacy (or by a pharmacist) for Concerta.

Janssen Pharmaceuticals, Inc., the maker of Concerta, also manufactures an authorized Concerta generic, which is sold as a generic by Actavis. The Actavis product is identical to Janssen’s Concerta and the FDA found it to be bioequivalent to, and substitutable for, Concerta.

For more information, please visit: more information here

Source: FDA
Publication Date: 2014-11-14
Last Updated: 2014-11-14

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