Isotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactu...
FDA Recall #D-0399-2026 — Class II — February 24, 2026
Product Description
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
Recalling Firm
MYLAN PHARMACEUTICALS INC — Morgantown, WV
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
34850 blister packs
Distribution
Nationwide within the United States
Code Information
Lot #: 3116110, 3116130, Exp. Date 07/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated