FDAHealthFebruary 24, 2026
MYLAN PHARMACEUTICALS INC — 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,
⚠️ Failed Dissolution Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 24, 2026
Nationwide within the United States
What's affected?
- 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.
- Brand
- AMNESTEEM
- Lot code
- 3116110
Additional details
Lot #: 3116110, 3116130, Exp. Date 07/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 34850 blister packs.
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