Warning
MYLAN PHARMACEUTICALS INC Recalls Amnesteem (Isotretinoin) Capsules
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0399-2026Drug / Pharmaceutical
MYLAN PHARMACEUTICALS INC Recalls Amnesteem (Isotretinoin) Capsules
MYLAN PHARMACEUTICALS INC · Class II — Moderate Risk
Product Description
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from MYLAN PHARMACEUTICALS INC, initiated on February 24, 2026. Failed Dissolution Specifications. This recall covers 34850 blister packs, distributed nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.