Lower risk Drug recall · FDA · Published November 15, 2019

Akorn recalls Myorisan 20mg capsules due to incorrect 40mg product mix-up

Akorn recalls Myorisan 20mg capsules (NDC 61748-302-13) after customer reports a carton contained one 40mg blister pack mistakenly with two 20mg packs. This could lead to incorrect dosing.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0647-2020Drug Akorn ›

Lower-risk 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.

Take action

Contact the company

Recalling firmAkorn, Inc.1925 W Field Ct Ste 300 · Lake Forest, IL 60045-4862

✎ GovInfoNow plain-language explainer

Akorn is recalling Myorisan 20mg capsules because some packages accidentally included a 40mg product instead of 20mg. This mix-up could cause incorrect dosing if taken without realizing the difference. Read more at govinfonow.com/recall/37691-akorn-recalls-myorisan-20mg-capsules-due-to-incorrect-40mg-product.

Source Summary by GovInfoNow · govinfonow.com/recall/37691-akorn-recalls-myorisan-20mg-capsules-due-to-incorrect-40mg-product · Updated October 5, 2026 · FDA enforcement record: FDA #D-0647-2020

Cite this page

“Akorn recalls Myorisan 20mg capsules due to incorrect 40mg product mix-up.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37691-akorn-recalls-myorisan-20mg-capsules-due-to-incorrect-40mg-product. Based on FDA recall #D-0647-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0647-2020%22&limit=1).

The FDA announced on 2019-11-15 that Akorn, Inc. is recalling MYORISAN (isotretinoin capsules, USP), 20mg due to unit dose mispackaging. The hazard involves erroneous inclusion of 40 mg product in cartons labeled as 20 mg.

How to tell if you have it

Brand: Akorn
Product: MYORISAN (isotretinoin capsules, USP), 20mg
Packaging: 30-count Capsules (3 x 10 Prescription Packs) per box
NDC: 61748-302-13
Lot Code: V20M54A
Expiration Date: 01/2021
Quantity: 4,206 boxes

The hazard

Customer complaints indicated that cartons 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.

Context

GovInfoNow's records show Akorn, Inc. has 64 other recalls on record since 2014-08-05. Other recent recalls include the 2023-04-26 Akorn Guaifenesin Oral Solution Recall for stability issues and the 2023-01-30 Akorn Atropine Sulfate Ophthalmic Solution 1% Recall for failed stability specifications. Similar recent recalls of other products include the 2025-12-31 Alvogen Thyro-Tabs 150mcg Tablets Recall for product mix-up risk and the 2026-06-17 Sun Pharmaceutical Perampanel 6mg Tablets Recall for label mix-up risk.

How to tell if you have this one

Check for the Myorisan 20mg capsules (NDC 61748-302-13) with a carton labeled as 20mg but containing one 40mg blister pack and two 20mg blister packs. The product was distributed by VersaPharm Inc. in the US.

Brand
Akorn
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Package
Look for a carton labeled Myorisan 20mg that contains one 40mg blister pack and two 20mg blister packs.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

Nov 15, 2019Firm started the recall
Jan 6, 2020FDA classified it Class II
Jan 8, 2020Published in FDA’s Enforcement Report
Aug 9, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/37691-akorn-recalls-myorisan-20mg-capsules-due-to-incorrect-40mg-product">Akorn recalls Myorisan 20mg capsules due to incorrect 40mg product mix-up (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0647-2020 (November 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0647-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.