# FDA recall D-1392-2019

> **Akorn Inc** · Class III · drug recall initiated 2019-06-07.

## 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.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1392-2019
- **Recalling firm:** Akorn Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-06-07
- **Report date:** 2019-06-26
- **Termination date:** 2022-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1392-2019

## Citation

> AI Analytics. FDA recall D-1392-2019. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-1392-2019. Source: US FDA. Licensed CC0.

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