The Recall Desk
ModerateFDA (Drugs)·D-0724-2021·Announced 2021-08-25

Combipatch Transdermal System Recalled for Failed Stability Specifications

Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day because certain lots failed stability specifications and tested out of specification 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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a failed stability specification (out of specification for shear), which represents a potential quality defect rather than an acute safety threat. The source text does not report any adverse events or clinical harm.

Plain-English summary

Noven Pharmaceuticals Inc is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 twice weekly (NDC 68968-0514-2 and 68968-0514-8) nationwide. The recall affects 223,382 boxes across four lots: Lot 88542 (expiration 03/2022), Lot 88227 (expiration 12/2021), Lot 88696 (expiration 05/2022), and Lot 89357 (expiration 08/2022).

The product is being recalled because certain lots failed stability specifications and tested out of specification for shear. This is a prescription transdermal patch used for hormone therapy.

Patients currently using Combipatch from the affected lots should contact their healthcare provider or pharmacist to determine whether they have a recalled product and to discuss continued treatment options. Healthcare providers and patients should not discontinue use without medical guidance.

The recalled product

Product
COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
Brand
COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
Manufacturer
Noven Pharmaceuticals Inc
Category
Drug — Hormone Therapy / Transdermal Patch
Hazard
  • failed-stability-specification
  • quality-defect

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)

  • Lots: 88542 Exp. 03/2022
  • 88227 Exp. 12/2021
  • 88696 Exp. 05/2022
  • 89357 Exp. 08/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)

Same category