Recall D-0399-2026

US Class II Ongoing · initiated 2026-02-24

Recalling firm

MYLAN PHARMACEUTICALS INC, WV

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 for recall

Failed Dissolution Specifications

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