Myorisan — Class III drug recall D-1392-2019
Terminated recall by Akorn Inc, reported 2019-06-26, distributed nationwide. Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is l
| Recall number | D-1392-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn Inc, Lake Forest, IL, United States |
| Recall initiated | 2019-06-07 |
| Classified | 2019-06-17 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2022-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 16,216 cartons |
| Reason classes | labeling |
| NDC | 61748-0304-13 |
| Lot numbers | 9/20, V30M56A |
Product
Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13
Reason for recall
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
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-1392-2019. 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.