FDA Drug recall D-0399-2026
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals…
- FDA Drug
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals… by Mylan Pharmaceuticals, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0399-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-24 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
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
Identifiers
| ndc | 0378-6611-85 |
|---|---|
| ndc | 0378-6611-93 |
| ndc | 0378-6612-85 |
| ndc | 0378-6612-93 |
| ndc | 0378-6613-85 |
| ndc | 0378-6613-93 |
| ndc | 0378-6614-85 |
| ndc | 0378-6614-93 |
| code_info | Lot #: 3116110, 3116130, Exp. Date 07/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0399-2026%22
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