Akorn recalls all batches of Artificial Tears Solution (Polyvinyl Alcohol 1.4%) due to inability to maintain product stability after the manufacturer ceased operations.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all batches of Artificial Tears Solution (Polyvinyl Alcohol :1.4%) because the company went out of business and can no longer perform stability testing. This means the product may not be safe for use as it could degrade over time.
The product's stability could be compromised because the manufacturer went out of business and stopped conducting necessary stability studies. Without these studies, the product may degrade over time, potentially causing eye irritation or other issues.
People who own or use Akorn's Artificial Tears Solution (Polyvinyl Alcohol 1.4%) are affected. Those with eye conditions requiring regular use are most at risk if the product degrades.
Check for the product name 'Artificial Tears Solution, Polyvinyl Alcohol 1.4%' on the label. All batches (all NDCs and lots) are included in this recall.
Look for the product name 'Artificial Tears Solution, Polyvinyl Alcohol 1.4%' on the label.
The manufacturer went out of business and can no longer continue stability studies, which means the product's safety and effectiveness cannot be guaranteed.
No specific action is required beyond checking if you have the product. The recall is for safety due to stability concerns, but the product is not immediately dangerous.
All batches of this product are recalled. Check the label for the product name and NDC numbers to confirm.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0785-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0785-2023 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.
