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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 i…

Failed Dissolution Specifications

Class II Medicine & devices FDA March 11, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
MYLAN PHARMACEUTICALS INC — Morgantown, WV
Severity
Class II — moderate
Reported
March 11, 2026
Quantity
34850 blister packs
Recall number
D-0399-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide within the United States

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