Edge Pharma recalls Betadine sterile ophthalmic solution due to lack of assurance of sterility. This could lead to infections if used improperly. Affected products were sold from 2021.
Lack of Assurance of Sterility
Edge Pharma is recalling Betadine sterile ophthalmic solution because it may not be sterile. Using this product could cause eye infections if it's contaminated.
The solution may not be sterile, which can lead to infections if it's contaminated. This is a risk during medical procedures or when treating eye injuries.
People who use this eye solution for medical purposes, especially those with eye injuries or infections. Those using the product without proper sterility checks are at higher risk.
Check for the product name 'Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe'. The NDC code 05446-1680-01 was used from 2021.
Look for the NDC code 05446-1680-01 on the product label.
The recall states there is a lack of assurance of sterility, so it may not be safe for use. Do not use this product.
Check for the NDC code 05446-1680-01 on the product label. The product was sold from 2021.
The recall does not specify a remedy, so contact Edge Pharma for further instructions.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0423-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0423-2022 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.
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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.
