MYLAN PHARMACEUTICALS INC recalls Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: M…

Recall date

February 24, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0399-2026

FDA classification

Class II

Brand / firm

MYLAN PHARMACEUTICALS INC

Sold / distributed

Nationwide within the United States

Why it was recalled

Failed Dissolution Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.