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

Is NDC 0378-7280-85 recalled?

Norethindrone Acetate and Ethinyl Estradiol

Yes — this exact package was recalled

1 FDA recall names the code 0378-7280-85 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
norethindrone acetate and ethinyl estradiol
Strength
ETHINYL ESTRADIOL .02 mg/1; NORETHINDRONE ACETATE 1 mg/1
Form
Tablet · Oral
Labeler
Mylan Pharmaceuticals Inc.
Type
Human Prescription Drug
Product code
0378-7280

Recalls naming this package

Class III · Low risk

Norethindrone Acetate and Ethinyl Estradiol Tablets

Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

Terminated Chemical / undeclared Mylan Pharmaceuticals Inc. NDC 0378-7280-85 D-0861-2017

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