MYLAN PHARMACEUTICALS INC recalls Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: My
Recalled March 11, 2026 · FDA recall D-0399-2026 · MYLAN PHARMACEUTICALS
Hazard
Failed Dissolution Specifications · FDA Class II
Units
34850 blister packs
Sold at
Nationwide within the United States
Description
Failed Dissolution Specifications
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.
Manufacturer(s)
MYLAN PHARMACEUTICALS INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →