⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

MYLAN PHARMACEUTICALS INC: Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals

DrugsSource: FDA (drug) · Date: 2026-03-11

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
MYLAN PHARMACEUTICALS INC
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 / hazard
Failed Dissolution Specifications
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2026-02-24
Code info
Lot #: 3116110, 3116130, Exp. Date 07/2026
Product quantity
34850 blister packs
Voluntary mandated
Voluntary: Firm initiated
City
Morgantown
State
WV
Country
United States
Event id
98477
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