Isotretinoin Recall: Amnesteem 40 mg Capsules
Announced 2026-03-11 · FDA
The FDA is recalling 34,850 blister packs of Amnesteem (Isotretinoin) 40 mg capsules packaged in 3 x 10-count prescription packs, Rx Only, distributed nationwide. The recall is due to failed dissolution specifications. Affected lots are 3116110 and 3116130 with expiration date 07/2026.
| Brand | MYLAN PHARMACEUTICALS INC |
|---|---|
| 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. |
| Reason | Failed Dissolution Specifications |
| Severity | moderate |
| Units affected | 34850 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
| Recall / campaign no. | Lot #: 3116110, 3116130, Exp. Date 07/2026 |
WHAT YOU SHOULD DO
- Do not use Amnesteem 40 mg capsules from affected lots.
- Check the packaging for lot numbers 3116110 or 3116130 and expiration date 07/2026; if present, stop using the product immediately.
- Contact your prescribing physician or pharmacist to discuss alternatives, replacement options, or safe disposal.
- If you experience any problems, report them to your healthcare provider and, if appropriate, the FDA MedWatch program.
Other MYLAN PHARMACEUTICALS INC recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.