Akorn Recalls Myorisan 20mg Capsules Due to Mispackaging Error
Akorn, Inc. is recalling Myorisan (isotretinoin) 20mg capsules because some cartons contained 40mg blister cards. The error was found in a customer complaint.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a packaging error leading to potential dosage discrepancy, which fits the Moderate severity criteria for labeling/packaging errors without reported serious injury.
Plain-English summary
Akorn, Inc. is recalling 4,206 boxes of Myorisan (isotretinoin capsules, USP) 20mg. The product is distributed by VersaPharm Inc. and was sold nationwide in the USA and Puerto Rico. The specific lot number is V20M54A with an expiration date of 01/2021.
The recall was initiated due to a customer complaint regarding unit dose mispackaging. A carton labeled as Myorisan 20 mg Capsules, USP was found to erroneously contain one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Consumers who have this product should check their medication for the specific lot number and expiration date. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on how to dispose of the medication or obtain a replacement.
The recalled product
- 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.
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 4,206
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot V20M54A
- Exp 01/2021
Distribution
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