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
Recall initiated: 20260224
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated