ADHD Patches Recalled

Noven Pharmaceuticals Inc is recalling more than a dozen lots of Daytrana patches due to defective delivery systems. The March 29, 2023, US Food and Drug Administration (FDA) Enforcement Report stated the patches are “out of specification for shear.”

The recall affects the following Daytrana (methylphenidate transdermal system) products, which were manufactured for Noven Therapeutics LLC, Miami, Florida, by Noven Pharmaceuticals and distributed throughout the United States:

• Daytrana, 10 mg, 30-count cartons (NDC 68968-5552-3), from lots 91955 (Exp. 7/23) and 93039 (Exp. 10/23);
• Daytrana, 15 mg, 30-count cartons (NDC 68968-5553-3), from lots 91956 (Exp. 6/23) and 92475 (Exp. 7/23);
• Daytrana, 20 mg, 30-count cartons (NDC 68968-5554-3), from lots 91957 (Exp. 7/23), 92197 (Exp. 7/23), 92476 (Exp. 9/23), and 92477 (Exp. 10/23); and 
• Daytrana, 30 mg, 30-count cartons (NDC 68968-5555-3), from lots 91474 (Exp. 3/23), 91959 (Exp. 3/23), 91958 (Exp. 6/23), 92478 (Exp. 7/23), 92479 (Exp. 8/23), 92198 (Exp. 8/23), 92199 (Exp. 9/23), 93040 (Exp. 9/23), and 93041 (Exp. 10/23).

Noven Pharmaceuticals voluntarily initiated the recall March 10, 2023. On March 20, 2023, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Daytrana is a prescription methylphenidate transdermal system indicated for the treatment of attention deficit hyperactivity disorder (ADHD).