Akorn, Inc. is recalling 4,206 boxes of Myorisan (isotretinoin capsules, USP) 20 mg due to a packaging error where some boxes may contain a higher dosage than labeled. A customer reported finding a 40 mg blister card inside a box labeled as containing only 20 mg capsules. Each box is supposed to contain three 10-count blister packs of the 20 mg strength, but affected units may erroneously include one 10-count pack of the 40 mg strength. Taking a higher dose of isotretinoin than prescribed can lead to unexpected side effects or toxicity.
Patients may inadvertently take a 40 mg dose of isotretinoin instead of the prescribed 20 mg dose, which doubles the intended medication amount. This packaging error poses a risk of adverse reactions associated with isotretinoin overdose or increased toxicity.
Pharmacy refund and healthcare consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.