Amnesteem recall (MYLAN PHARMACEUTICALS INC)
DrugClass IIOngoing
Summary: MYLAN PHARMACEUTICALS INC is recalling 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: Failed Dissolution Specifications.
What is 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.
Why
Failed Dissolution Specifications
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lot #: 3116110, 3116130, Exp. Date 07/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0399-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 24, 2026 |
| Reported | March 11, 2026 |
| Company | MYLAN PHARMACEUTICALS INC |
| Company location | Morgantown, WV, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 34850 blister packs |
More recalls from MYLAN PHARMACEUTICALS INC · all drug recalls · recalls from February 2026