FDA Drugs recall ·
Amnesteem (Isotretinoin) Capsules, USP 40 mg… recall
- Recall number
- D-0399-2026
- Date
- (initiated February 24, 2026)
- Company / brand
- Mylan Pharmaceuticals Inc
1311 Pineview Dr, Morgantown, WV, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 34850 blister packs
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Dissolution Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 3116110, 3116130, Exp. Date 07/2026
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0399-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.