The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1209-2018·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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the recall as FDA Class II. Per the severity rubric, an FDA Class II recall must be scored as 4 (Severe) regardless of whether specific injuries are reported, as it indicates a potential for temporary or medically reversible adverse health consequences.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling Minivelle (estradiol transdermal system) patches. The recall involves 26,217 boxes of 8 patches, specifically the 0.025 mg/day strength, distributed nationwide. The affected lots are 82199 (expiring 12/2018) and 83025 (expiring 05/2019).

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

Patients using Minivelle should contact their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative 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 (2)

  • Lots: 82199 Exp. 12/2018
  • 83025 Exp. 05/2019

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 →

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