Akorn recalls sterile eye ointment due to stability concerns after the company went out of business and could no longer conduct stability testing.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling sterile artificial tears ointment tubes because the company went out of business and can no longer ensure the product remains stable. This means the ointment may not be safe for use once opened.
The company went out of business and stopped stability testing, which means the product's safety and effectiveness over time cannot be guaranteed. This could lead to the ointment becoming ineffective or causing irritation once opened.
People who own or use the recalled sterile eye ointment tubes. Those with open wounds or sensitive eyes may be at slightly higher risk.
The product is sterile artificial tears ointment in 3.5 gram tubes. All lots and all National Drug Codes (NDCs) are affected.
Look for the product name and NDC numbers on the tube to confirm it is part of the recall.
The company went out of business and could no longer continue stability studies, so the product's safety and effectiveness over time cannot be guaranteed.
No fix is available; the product must be discarded or returned as the company no longer operates.
The product is sterile artificial tears ointment in 3.5 gram tubes with all NDCs and lots affected.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0786-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0786-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.