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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 Device
Medical Devices/Diagnostic Equipment

EMD Millipore Corporation: Lugol’s Iodine Solution Recalled for Improper Bottle Seal and Evaporation

Agency Publication Date: November 29, 2023
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Summary

EMD Millipore Corporation is recalling 5 units of Lugol’s Iodine Solution (500ML) due to the use of incorrect packaging. The affected product, identified by Part Number 624-71 and Lot Number 3124, has an improper seal between the cap and the bottle. This defect allows iodine vapors to escape, causing the concentration of the solution to drop below its required specifications over time. These units were distributed in California, New Jersey, and West Virginia.

Risk

The improper seal allows iodine vapors to dissipate from the bottle, which reduces the potency of the solution. This can lead to inaccurate laboratory results or ineffective use in medical applications because the concentration will be lower than the required 24.8 to 27.2 mL specification.

What You Should Do

  1. Check your inventory for Lugol’s Iodine Solution 500ML with Part Number 624-71 and Lot Number 3124.
  2. Immediately stop using any product identified from Lot Number 3124 as the concentration may be inaccurate.
  3. Contact your healthcare provider or EMD Millipore Corporation for further instructions regarding the affected product and to discuss potential replacement or refund options.
  4. For additional information, you can contact the manufacturer at their Burlington, Massachusetts headquarters at 400 Summit Dr, or visit their website.
  5. If you have further questions or concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer initiated recall via notification letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Lugol s Iodine Solution 500ML
Model / REF:
624-71
Lot Numbers:
3124

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93318
Status: Active
Manufacturer: EMD Millipore Corporation
Sold By: EMD Millipore Corporation
Manufactured In: United States
Units Affected: 5 units
Distributed To: California, New Jersey, West Virginia

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 · 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.