The Recall Desk
ModerateFDA (Drugs)·D-1208-2018·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 is a physical adhesive issue (shear) rather than a chemical contamination or high-risk pathogen. No illnesses or injuries are reported, 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 149,631 boxes of 8 patches and 15,809 boxes of 2 patches, which were distributed nationwide. The affected products are prescription-only and deliver 0.05 mg/day of estradiol.

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 products should stop using them and contact their healthcare provider or pharmacist for guidance. The affected lots include lot numbers 82292 (Exp. 02/2019), 82139 (Exp. 10/2018), and 82598 (Exp. 04/2019). The NDC for the 8-count box is 68968-6650-8.

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 (4)

  • a) 82292 Exp. 02/2019
  • b) 82139 Exp. 10/2018
  • 82292 Exp. 02/2019
  • and 82598 Exp. 04/2019

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

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Same hazard · adhesive defect

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