Akorn recalls Neomycin and Polymyxin B Sulfates ointment tubes because the manufacturer went out of business and can no longer ensure product stability.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling Neomycin and Polym: B Sulfates ophthalmic ointment tubes due to the manufacturer going out of business and being unable to continue stability testing. This means the ointment may not be safe for use as it could degrade over time.
The manufacturer went out of business and can no longer perform stability studies. This means the ointment's quality and safety could degrade over time, potentially causing eye irritation or infection.
People with prescriptions for this ointment are affected. Those who have the product and are using it for eye infections are most at risk.
Check for Neomycin & Polymyxin B Sulfates ophthalmic ointment tubes labeled 3.5 g, Rx Only, manufactured by Akorn, Inc. in Lake Forest, IL. All lots and all NDC numbers are affected.
Identify the product by checking the label for Neomycin & Polymyxin B Sulfates ophthalmic ointment, 3.5 g tubes, Rx Only, manufactured by Akorn, Inc.
The manufacturer went out of business and can no longer continue stability studies, which means the product's safety and quality may degrade over time.
The official recall does not provide a remedy, so no action is needed beyond checking if you have the product.
Check for Neomycin & Polymyxin B Sulfates ophthalmic ointment tubes labeled 3.5 g, Rx Only, manufactured by Akorn, Inc. in Lake Forest, IL. All lots and all NDC numbers are affected.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0831-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0831-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
