Class IIReported 2026-03-11

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.

Recalled by MYLAN PHARMACEUTICALS INC

Reason for Recall

Failed Dissolution Specifications

Recall Number

D-0399-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2026-02-24

Reported

2026-03-11

Distribution

Nationwide within the United States

Code Info

Lot #: 3116110, 3116130, Exp. Date 07/2026

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.