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FDARecalled Mar 11, 2026 · #D-0399-2026

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...

Hazard

Class II — temporary health risk

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Description

Failed Dissolution Specifications Classification: Class II Distribution: Nationwide within the United States

Product details

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.
Type
Drugs
Manufacturer
MYLAN PHARMACEUTICALS INC
Model numbers
3116110
UPCs