Amnesteem — Class II drug recall D-0399-2026
Ongoing recall by MYLAN PHARMACEUTICALS INC, reported 2026-03-11, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0399-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MYLAN PHARMACEUTICALS INC, Morgantown, WV, United States |
| Recall initiated | 2026-02-24 |
| Classified | 2026-03-19 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 34,850 blister |
| Reason classes | specification failure |
| NDC | 00378-6611, 00378-6611-85, 00378-6611-93, 00378-6612, 00378-6612-85, 00378-6612-93, 00378-6613, 00378-6613-85, 00378-6613-93, 00378-6614, 00378-6614-85, 00378-6614-93 |
| Lot numbers | 3116110, 3116130 |
| Expiration dates | 2026-07 |
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 for recall
Failed Dissolution Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0399-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.