Edge Pharma, LLC recalls Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT)
Edge Pharma recalls Betadine 5% ophthalmic solution due to potential contamination from syringe migration. Affected lots from May 2021 may cause infection if used improperly.
Lower-risk recall
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Contact the company & request your remedy
What happened, in plain English
Edge Pharma is recalling Betadine 5% ophthalmic solution because the syringe container may allow contamination. This could lead to eye infections if the solution is not sterile. Read more at govinfonow.com/recall/36214-edge-pharma-betadine-ophthalmic-solution-recall-risk-of-contaminated-solution.
Source Summary by GovInfoNow · govinfonow.com/recall/36214-edge-pharma-betadine-ophthalmic-solution-recall-risk-of-contaminated-solution · Updated October 4, 2026 · FDA enforcement record: FDA #D-0335-2021
Cite this page
“Edge Pharma Betadine Ophthalmic Solution Recall: Risk of Contaminated Solution.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36214-edge-pharma-betadine-ophthalmic-solution-recall-risk-of-contaminated-solution. Based on FDA recall #D-0335-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0335-2021%22&limit=1).
Why it’s dangerous
The syringe's seal may allow solution to migrate past the plunger, potentially causing contamination. This could lead to eye infections if the solution is not sterile.
Who’s affected
People who have purchased the Betadine ophthalmic solution from Edge Pharma. Those using the solution for eye irrigation or minor eye care are most at risk.
How to tell if you have this one
Check for the lot number 02-2021-16@4 with a batch date of May 2021. The product is a single-use syringe for topical eye use only, not for injection.
- Brand
Edge Pharma- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 02-2021-16@4 on the syringe packaging.
Questions people ask
Is this product safe to use?
The product may not be sterile due to potential contamination, so it is not recommended for use.
What should I do if I have this product?
The official recall does not specify a return or disposal method, but you should check with Edge Pharma customer service for guidance.
Can I use this product for injection?
No, the product is labeled for topical ophthalmic use only and should not be injected.
Contact Edge Pharma
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0335-2021 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0335-2021 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.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
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.
- Official source: FDA Recall #D-0335-2021 (April 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0335-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.