Why it was recalled
Failed Dissolution Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 3116110, 3116130, Exp. Date 07/2026
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0399-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 24, 2026
- FDA report date
- Mar 11, 2026
- Quantity
- 34850 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MYLAN PHARMACEUTICALS INC
Original FDA data
Every field from FDA enforcement report D-0399-2026, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Ongoing
- Country
- United States
- Event ID
- 98477
- Address
- 1311 Pineview Dr
- Code information
- Lot #: 3116110, 3116130, Exp. Date 07/2026
- Postal code
- 26505-3276
- Report date
- Mar 11, 2026
- Product type
- Drugs
- Recall number
- D-0399-2026
- Classification
- Class II
- Recalling firm
- MYLAN PHARMACEUTICALS INC
- Product quantity
- 34850 blister packs
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 24, 2026
- Initial firm notification
- Letter
- Center classification date
- Mar 19, 2026