Shire Recalls Daytrana ADHD Patches in ‘Voluntary Market Withdrawal’

Shire admits there’s a problem with the Daytrana ADHD patch, and fixes it. Following strong feedback from our readers and other users of the Daytrana patch, the company has announced a ‘voluntary market withdrawal’ of faulty Daytrana patches. The company says it is now using an ‘enhanced process’ to ensure the backing of the patch can be easily removed.

Sometimes, feedback works.

With a regular stream of user reports coming directly from this website, as well as from many other patients and doctors, Daytrana patch manufacturer Shire Pharmaceuticals has admitted there is a problem with large numbers of the methylphenidate transdermal system patches for ADHD.

The official product withdrawal notice is available directly from Shire, and here is the letter which has been sent out to patients and caregivers, including the lot numbers for affected batches and instructions on what to do if your medication is affected:

Dear Daytrana™ Patients and Caregivers:

Shire wants to advise you of the company’s decision to implement a voluntary market withdrawal of limited portions of the Daytrana™ patches. Shire is taking this proactive step not due to safety and efficacy issues, but due to feedback from patients and caregivers who have experienced difficulty removing the release liner from some Daytrana™ patches.

Shire expects the remaining supply of Daytrana™ will offer patients and caregivers improved ease of use when peeling the release liner off the patch. All Daytrana™ patches, including those that are part of the voluntary market withdrawal, can continue to be used unless the release liner cannot be removed or the patches are damaged while being opened. The current supply levels of Daytrana™ are sufficient, ensuring that those patients who currently use Daytrana™ and those patients looking for an alternative ADHD treatment option will be able to have their prescriptions filled with Daytrana™ patches with an improved ease of use.

Here is important information you should know about this voluntary market withdrawal:

Are the affected lots safe and effective?

Shire is taking this proactive step not due to safety and efficacy issues, but due to feedback from patients and caregivers who have experienced difficulty removing the release liner from some Daytrana™ patches. All Daytrana™ patches, including those affected by the voluntary market withdrawal, can be used unless the release liner cannot be removed or the patches are damaged.

How do I know if my current supply of Daytrana™ is affected by this voluntary market withdrawal?

Only those Daytrana™ packages that have an expiration date of March 31, 2009 or earlier or lots 2563511, 2563611, or 2570411 are impacted by this voluntary market withdrawal. All Daytrana™ patches including those affected by the voluntary market withdrawal can continue to be used unless the patches are damaged when opening or the release liner cannot be removed.

What should parents and caregivers of patients prescribed Daytrana™ do with their packages of Daytrana™ if they meet the criteria for the voluntary market withdrawal?

They have two options:

  • If the release liners can be easily removed and the patches are not damaged, use the patches as directed.
  • Or, if the patches cannot be used, call the Shire Customer Service/DaytranaCare line at 1-800-828-2088, option 1.

Please see Important Safety Information below and accompanying Full Prescribing Information.

Please describe what you mean by “damaged.”

If it appears to you that anything about a patch looks unusual, please do not use. Damaged patches should be discarded according to the directions in the Daytrana™ package insert.

What changes have been made to Daytrana™?

We have increased the release coating on the release liner. No changes to the medication, itself, have been made.

At Shire our patients always come first and Shire is dedicated to providing you with the information you need to make informed decisions related to your child’s care. If you have further questions after reviewing this information, please call us at 1-800-828-2088, option 1.

Sincerely,
Joel Cohen, MD
Medical Director, Global Medical Affairs
Shire Pharmaceuticals

All clinical material on this site is peer reviewed by one or more clinical psychologists or other qualified mental health professionals. This specific article was originally published by on and was last reviewed or updated by Dr Greg Mulhauser, Managing Editor on .

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