FDA recall, , Moderate risk
Mylan Amnesteem Isotretinoin Capsules
Amnesteem (Isotretinoin) Capsules, USP 40 mg failed dissolution specifications.
Summary by Recall Canary from the FDA notice
What happened
Mylan Pharmaceuticals Inc., of Morgantown, West Virginia, recalled Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, because the product failed dissolution specifications. The recall began on February 24, 2026, and was added to the FDA's Enforcement Report on March 4, 2026. The product was distributed nationwide within the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Amnesteem (Isotretinoin) Capsules, USP 40 mg
- NDC
- 0378-6614-93
- Lot code
- 3116110
- 3116130
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- MYLAN PHARMACEUTICALS INCMorgantown, West Virginia
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98477
- Recall number
- D-0399-2026
- Quantity recalled
- 34850 blister packs
All recalls from MYLAN PHARMACEUTICALS INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Listed on Recall Canary
Summary updated
