FDA recall D-0399-2026

Product

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.

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2026-02-24

Report date

2026-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0399-2026