← FDA ENFORCEMENT
D-0399-2026Class II

MYLAN PHARMACEUTICALS INC

Recalling firm
MYLAN PHARMACEUTICALS INC
Product type
Drug
Status
Ongoing
Report date
2026-03-11
Distribution
Nationwide within the United States
Firm state
WV
Product quantity
34850 blister packs
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Dissolution Specifications

Product description

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.

Code / lot info

Lot #: 3116110, 3116130, Exp. Date 07/2026

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.