Lower riskDrug recall · FDA · Published June 7, 2019
Akorn Myorisan 40mg Capsules: Label Mix-Up Risk
Akorn recalls Myorisan 40mg isotretinoin capsules due to label mix-up in packaging. The secondary carton incorrectly states 40mg instead of 30mg, while the primary carton is labeled correctly. This may cause confusion about dosage.
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Take action
Contact the company
📍Recalling firmAkorn Inc1925 W Field Ct Ste 300 · Lake Forest, IL 60045-4862
✎ GovInfoNow plain-language explainer
Akorn is recalling Myorisan (isotretinoin capsules) because the secondary packaging incorrectly states 40mg instead of 30mg. This labeling error could lead to confusion about the correct dosage, which is important since isotretinoin is a potent medication that requires precise dosing. Read more at govinfonow.com/recall/38720-akorn-myorisan-40mg-capsules-label-mix-up-risk.
“Akorn Myorisan 40mg Capsules: Label Mix-Up Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38720-akorn-myorisan-40mg-capsules-label-mix-up-risk. Based on FDA recall #D-1392-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1392-2019%22&limit=1).
The FDA announced on June 7, 2019, that Akorn Inc. is recalling Myorisan (isotretinoin capsules, USP), 40 mg, due to a labeling error where the secondary carton incorrectly states 40 mg instead of 30 mg. The agency stated the recall was voluntary and initiated by the firm.
How to tell if you have it
Brand: Akorn
Product: Myorisan (isotretinoin capsules, USP)
Strength: 40 mg
Packaging: Cartons of 30 Capsules containing 3 x 10 Prescription Packs
NDC: 61748-304-13
Lot Code: V30M56A
Expiration Date: 9/20
Distributor: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045
Quantity: 16,216 cartons
Distribution: Nationwide USA
The hazard
The product's secondary carton erroneously states 40 mg instead of the correct 30 mg strength, although the primary carton is labeled correctly. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Akorn, Inc. has 64 other recalls on record since August 5, 2014. Recent brand recalls include an April 26, 2023 Naloxone Injection recall for stability studies not completed and a January 30, 2023 Atropine Sulfate Ophthalmic Solution recall for failed stability specifications. Other recent recalls of similar products include an August 19, 2026 American Health Packaging Buprenorphine Tablets recall for label mix-up hazard and a June 17, 2026 Sun Pharmaceutical Perampanel 6mg Tablets recall for label mix-up risk.
How to tell if you have this one
Check for the secondary carton labeled 40mg instead of 30mg. The product is packaged in cartons of 30 capsules containing 3 x 10 prescription packs, with NDC 61748-304-13 and lot number V30M56A.
Brand
Akorn
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Labeling
Verify the secondary carton label states 40mg instead of 30mg. If so, this is the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1392-2019 (June 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1392-2019 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.