Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 68968-6610-01 recalled?

Minivelle

Yes — this exact package was recalled

1 FDA recall names the code 68968-6610-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
estradiol
Strength
ESTRADIOL .1 mg/d
Form
Film, Extended Release · Transdermal
Labeler
Noven Therapeutics, LLC
Type
Human Prescription Drug
Product code
68968-6610

Recalls naming this package

Class II · Moderate risk

Minivelle (estradiol transdermal system)

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-6610-8 D-1207-2018
Class II · Moderate risk

Minivelle (estradiol transdermal system)

Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-6610-1 D-0862-2018
Class III · Low risk

Minivelle (estradiol Transdermal System)

Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.

Terminated Packaging defect Noven Pharmaceuticals, Inc. D-0923-2017

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler