United StatesAmnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10‑count prescription packs (NDC 0378-6614-93), made in France for Mylan Pharmaceuticals Inc., lot numbers 3116110 and 3116130, Exp. Date 07/2026, is being recalled. The recall was initiated because the product failed dissolution specifications.
What's being recalled
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.
Recalling firm: Mylan Pharmaceuticals Inc, Morgantown, WV, United States.
How to identify it
Lot #: 3116110, 3116130, Exp. Date 07/2026
The hazard
Failed Dissolution Specifications
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)