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.
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | Medium |
| Status | ongoing |
| Recall date | February 24, 2026 |
| Reported | March 11, 2026 |
| Recalling firm | MYLAN PHARMACEUTICALS INC |
| Country / region | United States WV |
Hazard
Failed Dissolution Specifications
Affected products
- Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV
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