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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Edge Pharma, LLC: Betadine Ophthalmic Solution Recalled for Defective Syringe and Sterility Risk

Agency Publication Date: April 19, 2021
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Summary

Edge Pharma, LLC is recalling 5,850 units of Betadine (Povidone-Iodine) 5% sterile ophthalmic solution due to a defect in the syringe container. The solution, which is used topically for eye procedures, was found to have contents migrating past the plunger seal, which can compromise the product's sterility. This recall affects single-use syringes from Lot 02-2021-16 distributed nationwide in the US. Consumers should not use the affected product and should contact their healthcare provider or pharmacist immediately.

Risk

The defect allows the liquid medication to move past the plunger's seal, which may introduce contaminants into the syringe. This creates a lack of assurance of sterility, potentially leading to serious eye infections if used during ophthalmic procedures.

What You Should Do

  1. Check your medical supplies for Betadine (Povidone-Iodine) 5%, 0.5mL single-use syringes with Lot number 02-2021-16 and a 'Best Use By' (BUD) date of 5/31/2021.
  2. Immediately stop using any syringes from the affected lot and set them aside to ensure they are not used on patients.
  3. Contact your healthcare provider or pharmacist for guidance regarding alternative products and to discuss any concerns if the product has already been used.
  4. Return any unused syringes from Lot 02-2021-16 to the place of purchase for a refund.
  5. Contact Edge Pharma, LLC Customer Service at 1-802-992-1178 for further instructions on returning the product.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy return.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe
Lot Numbers:
02-2021-16 (BUD 5/31/2021)
Date Ranges: Expires 05/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87710
Status: Resolved
Manufacturer: Edge Pharma, LLC
Sold By: Edge Pharma, LLC
Manufactured In: United States
Units Affected: 5850 syringes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.