# FDA recall D-0647-2020

> **Akorn, Inc.** · Class II · drug recall initiated 2019-11-15.

## Product

MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by:  VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.

## Reason for recall

Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0647-2020
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-15
- **Report date:** 2020-01-08
- **Termination date:** 2022-08-09

- **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-0647-2020

## Citation

> AI Analytics. FDA recall D-0647-2020. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/D-0647-2020. Source: US FDA. Licensed CC0.

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