The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0485-2015·Announced 2015-04-22

Noven Pharmaceuticals Recalls Minivelle Estradiol Patches Due to Temperature Abuse

Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because prolonged exposure to temperatures outside labeled storage conditions may affect product quality.

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 2/5 (Moderate).

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 involves a quality control issue (temperature abuse) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 720 Minivelle (estradiol) transdermal patches, 0.05 mg/day, 8-count boxes. The specific lot affected is #76476 with an expiration date of 07/16. The product is distributed nationwide.

The recall was initiated due to temperature abuse, defined as prolonged exposure to temperatures outside of the labeled storage conditions. This condition may compromise the integrity of the transdermal system.

Consumers and healthcare providers with this specific lot should stop using the product and contact their pharmacist or Noven Pharmaceuticals for instructions on return or replacement.

The recalled product

Product
MINIVELLE (ESTRADIOL)
Brand
MINIVELLE
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
720

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)

  • Lot # 76476
  • Exp 07/16

UPCs (1)

  • 0368968665083

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · MINIVELLE

Same manufacturer · Noven Pharmaceuticals, Inc.

See all →

Same hazard · temperature abuse

See all →

Similar recalls