Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Myorisan (isotretinoin capsules Recalled by Akorn Inc Due to Labeling: Label mix-up: Product secondary carton erroneously states...

Date: June 7, 2019
Company: Akorn Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Akorn Inc directly.

Affected Products

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

Quantity: 16,216 cartons

Why Was This Recalled?

Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Akorn Inc

Akorn Inc has 15 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report