The Recall Desk
ModerateFDA (Drugs)·D-0296-2021·Announced 2021-03-10

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system is out of specification for mechanical peel.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The defect is a mechanical issue with the delivery system, and no specific injuries or illnesses are reported in the source text.

Plain-English summary

Noven Pharmaceuticals Inc. is recalling 934,140 patches of Daytrana (methylphenidate transdermal system). The product is a prescription medication that delivers 30 mg of methylphenidate over 9 hours. The recall affects specific lots with expiration dates ranging from March 2021 to August 2021.

The recall was initiated because the product's delivery system is out of specification for mechanical peel. This defect relates to the physical integrity of the patch's delivery mechanism.

The affected product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the pharmacy or supplier for disposal or credit.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals Inc
Category
Drug — Prescription Transdermal
Hazard
Affected units
934,140

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 (16)

  • Lots #: 87377
  • Exp 3/2021
  • 87572
  • 87581
  • Exp 4/2021
  • 87820
  • Exp 5/2021
  • 88246
  • Exp 6/2021
  • 88535
  • Exp 7/2021
  • 88536
  • Exp 8/2021
  • 88537
  • Exp 8/2021 & 88939
  • Exp 8/2021.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Noven Pharmaceuticals Inc 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 4 products in this recall →

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