FDAFDA · Food and drugs·Recall number D-0399-2026
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.
Published March 11, 2026 · Recall initiated: February 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMNESTEEM
- Manufacturer
- MYLAN PHARMACEUTICALS INC
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 3116110, 3116130, Exp. Date 07/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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