The FDA announced on July 12, 2012, that Noven Pharmaceuticals Inc. is recalling Daytrana transdermal patches due to a defective delivery system. The agency stated the recall was voluntary and initiated by the firm.
How to tell if you have it
- Brand: Daytrana
- Product: Daytrana Transdermal Patch
- Dosage: Delivers 15 mg over 9 hours (1.6 mg/hr)
- Packaging: 1 patch per pouch, 30-count patches per box
- NDC: 68968-5553-3
- Lot Code: #53823
- Expiration Date: Exp 08/12
- Distribution: Nationwide and Puerto Rico
The hazard
According to the FDA, the patches have a miscalibrated or defective delivery system with out-of-specification mechanical peel force or z-statistic values. These defects relate to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Context
GovInfoNow's records show Noven Pharmaceuticals Inc has 24 other recalls on record since July 5, 2011. Other recent recalls of similar products include Noven Daytrana 20mg Transdermal System Recall (March 10, 2023) and Noven Xelstrym 13.5mg Transdermal System Recall (Oct. 31, 2024). Other recent recalls of similar products include Blossom Pharmaceuticals Dynagel Wound Hydrogel Recall (Oct. 31, 2025), Blossom Pharmaceuticals Dynashield Skin Protectant Recall (Oct. 31, 2025), and Pro N: 5% Lidocaine Tattoo Numbing Spray Recall (Feb. 2, 2026).