The Recall Desk
ModerateFDA (Drugs)·D-1210-2018·Announced 2018-10-03

Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defects

Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.

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, but the source text describes a manufacturing defect (adhesive shear) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling specific lots of Minivelle (estradiol) transdermal system patches. The recall involves 74,908 boxes of 8 patches, each delivering 0.075 mg/day. The affected lots are 82599 (Exp. 05/2019), 82660 (Exp. 03/2019), and 83396 (Exp. 09/2019). The product was distributed nationwide.

The recall was initiated due to a defective delivery system. Specifically, the transdermal patches produced out-of-specification results for shear, an attribute related to the adhesive properties of the patches. This defect may affect the patch's ability to adhere properly to the skin.

Consumers who have these specific lots of Minivelle patches should stop using them and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MINIVELLE (ESTRADIOL)
Brand
MINIVELLE
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard

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 (3)

  • Lots: 82599 Exp. 05/2019
  • 82660 Exp. 03/2019
  • 83396 Exp. 09/2019

UPCs (1)

  • 0368968665083

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 →

Related recalls

Same brand · MINIVELLE

Same manufacturer · Noven Pharmaceuticals, Inc.

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Same hazard · adhesive defect

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