Edge Pharma recalls 10%/1%/0.3%/0.125% ophthalmic solution due to lack of sterility assurance. This may cause infections. Check NDC 05446-1270-01 for affected units.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific eye drop solution because it may not be sterile. Using this product could lead to eye infections. Consumers should check the product label for the NDC number to see if they have the recalled item.
The product lacks assurance of sterility, meaning it might contain harmful bacteria. This can cause eye infections, especially in people with weakened immune systems or existing eye issues.
People who own or use this eye drop solution are affected. Those with compromised immune systems or existing eye conditions may be at higher risk.
Check the product label for the NDC number 05446-1270-01. The product was sold between December 2021 and January 2022.
Look for the NDC number 05446-1270-01 on the label.
The recall states there is a lack of assurance of sterility, which could lead to infections. The product is not safe to use as recalled.
Check the product label for the NDC number 05446-1270-01. The product was sold between December 2021 and January 2022.
The recall does not specify a remedy, so contact Edge Pharma directly for guidance.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0414-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0414-2022 from Edge Pharma. 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.
