The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0725-2021·Announced 2021-08-25

Combipatch Transdermal Patch Recall Due to Stability Failure

Noven Pharmaceuticals is recalling certain lots of Combipatch (estradiol/norethindrone acetate transdermal system) distributed nationwide because the patches failed stability testing and fell out of specification for shear properties.

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: This is an FDA Class II recall for a stability and manufacturing-specification failure. No illnesses, injuries, or deaths are reported in the source text. The hazard is potential reduced efficacy or delivery inconsistency due to out-of-specification shear properties, which is a quality and performance issue rather than an acute safety threat.

Plain-English summary

Noven Pharmaceuticals Inc is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day in packages of 2 systems (NDC 68968-0525-2) and 8 systems (NDC 68968-0525-8). The recall affects lots 88540 (expiration 03/2022), 89118 (expiration 05/2022), 89244 (expiration 07/2022), and a sample lot 89244 (expiration 07/2022). The product was distributed nationwide.

The patches are being recalled because they failed stability specifications and were found to be out of specification for shear properties. Shear refers to the physical integrity and adhesive properties of the transdermal patch.

Patients who have this product should consult their healthcare provider about continued treatment options. Healthcare providers and patients who have questions about this recall can contact Noven Therapeutics LLC or the FDA for more information.

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 — Transdermal Patch / Hormone Replacement
Hazard
Affected units
70,638

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: 88540 Exp. 03/2022
  • 89118 Exp. 05/2022
  • 89244 Exp. 07/2022
  • 89244 (sample lot) Exp. 07/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

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

Same manufacturer · Noven Pharmaceuticals Inc

See all →

Same hazard · stability failure

See all →

Similar recalls