The Recall Desk
ModerateFDA (Drugs)·D-1207-2018·Announced 2018-10-03

Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defect

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, and the defect relates to the physical adhesive properties of the patch rather than a chemical contamination or high-risk pathogen, fitting the criteria for a moderate severity recall.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling specific lots of Minivelle (estradiol) transdermal patches. The recall involves 213,714 boxes of 8 patches and 15,927 boxes of 2 patches. These prescription-only patches are distributed nationwide.

The recall was initiated because the delivery system of the patches produced out-of-specification results for shear, an attribute related to the adhesive properties of the transdermal patches. This defect may affect how the patch adheres to the skin.

Patients currently using Minivelle patches should check their lot numbers and expiration dates against the list provided by the manufacturer or their healthcare provider. If a patient has a recalled lot, they should stop using the product and contact their healthcare provider for guidance on alternative treatment options.

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 (7)

  • a) 82200 Exp. 01/2019 b) 81637 Exp. 10/2018
  • 82200 Exp. 01/2019
  • 82293 Exp. 02/2019
  • 82600 Exp. 04/2019
  • 83027 Exp. 04/2019
  • 83173 Exp. 06/2019
  • 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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