Recall: D-0399-2026

Class II - Potentially Harmful

Class IIClassification

2026-02-24Initiated

OngoingStatus

MYLAN PHARMACEUTICALS INCFirm

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

Failed Dissolution Specifications

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.