Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System
Noven Therapeutics is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed mechanical peel and shear specifications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving structural or mechanical defects in drug delivery systems that could impact efficacy or safety.
Plain-English summary
Noven Therapeutics, LLC is recalling 7,957 30-count boxes of Daytrana (methylphenidate) transdermal systems. The affected product is the 10 mg over 9 hours (1.1 mg/hr) strength, NDC 68968-5552-3, with Lot 86647 and an expiration date of 09/2020. The product was distributed nationwide in the US.
The recall was initiated because the product's delivery system was found to be out of specification for mechanical peel and shear. This defect relates to the physical integrity of the transdermal patch mechanism.
Consumers who have this specific lot of Daytrana should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as FDA Class II.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Therapeutics, LLC
- Category
- Drug — Transdermal Patch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 86647 Exp. 09/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Noven Therapeutics, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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