Daytrana (Methylphenidate)

Safety Alerts and Recalls

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

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:
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 tabl ...
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