Amnesteem (Isotretinoin) Capsules, USP 40 mg

MYLAN PHARMACEUTICALS INC has recalled Amnesteem (Isotretinoin) Capsules, USP 40 mg, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on March 11, 2026 and was initiated on February 24, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Amnesteem (Isotretinoin) Capsules, USP 40 mg, with approximately 34850 blister packs affected. The company behind the recall is MYLAN PHARMACEUTICALS INC, based in Morgantown, WV. The FDA describes the product as: “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.”

Why was Amnesteem (Isotretinoin) Capsules, USP 40 mg recalled?

According to the FDA, the stated reason for the recall is: “Failed Dissolution Specifications.” In plain terms, this recall relates to a potency or effectiveness issue.

This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.

What should you do?

If you think you may have bought Amnesteem (Isotretinoin) Capsules, USP 40 mg, compare it against the product description and identifying codes (Lot #: 3116110, 3116130, Exp. Date 07/2026) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact MYLAN PHARMACEUTICALS INC or your local health authority.

About this recall

This recall was distributed in WV. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.