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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
Medical Devices/Contact Lenses & Vision

MSM Nutraceuticals, LLC: Various MSM Eye Drops Recalled for Lack of Sterility

Agency Publication Date: April 15, 2019
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Summary

MSM Nutraceuticals, LLC is recalling approximately 5,900 bottles of various eye drop products, including 15% MSM, Dry Eye, Red Eye, and Dr. Berne's MSM Drops. These products were manufactured without proper terminal sterilization or testing required by safety standards to ensure they are free from microorganisms. Using non-sterile eye drops can lead to serious eye infections that may cause permanent vision loss. Consumers should immediately stop using these products and contact their healthcare provider or pharmacist for guidance.

Risk

The eye drops were not sterilized or tested to ensure they are free from bacteria and fungi, posing a risk of infection when applied directly to the eye. If a non-sterile product is used, microorganisms can enter the eye tissue, potentially leading to inflammation, infection, and long-term ocular damage.

What You Should Do

  1. Check your eye drop bottle for Lot Number 1808051 with an Expiration Date of 01/01/22.
  2. Identify the specific affected product names and UPC codes: 15% MSM Eye Drops (UPC 8 54582 00120 3), Dry Eye Drops (UPC 8 54582 00119 7), Red Eye Drops (UPC 8 54582 00118 0), or Dr. Berne's MSM DROPS 15% Solution (UPC 00854582001036).
  3. Immediately stop using any of these affected products and contact your healthcare provider or pharmacist if you have used them and are experiencing any eye-related issues.
  4. Return any unused product to the place of purchase for a full refund and contact MSM Nutraceuticals, LLC for further instructions.
  5. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare consultation and refund

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

Affected Products

Product: 15% MSM, Eye Drops (30ml, 1.014 oz.)
Model:
D-1126-2019
UPC Codes:
854582001203
Lot Numbers:
1808051 (Exp. Date 01/01/22)
Date Ranges: 01/01/22
Product: Dry Eye, Eye Drops (15ml, 0.51 fl oz.)
Model:
D-1127-2019
UPC Codes:
854582001197
Lot Numbers:
1808051 (Exp. Date 01/01/22)
Date Ranges: 01/01/22
Product: Red Eye, Eye Drops (15ml, 0.15 fl oz.)
Model:
D-1128-2019
UPC Codes:
854582001180
Lot Numbers:
1808051 (Exp. Date 01/01/22)
Date Ranges: 01/01/22
Product: Dr. Berne's MSM DROPS 15% Solution (30ml, 1.014 oz.)
Model:
D-1129-2019
SKU#182
UPC Codes:
00854582001036
Lot Numbers:
1808051 (Exp. Date 01/01/22)
Date Ranges: 01/01/22

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82421
Status: Resolved
Manufacturer: MSM Nutraceuticals, LLC
Sold By: Dr. Berne's Whole Health Products; Retailers nationwide
Manufactured In: United States
Units Affected: 4 products (5000 30 ml bottles; 200 15ml bottles; 200 15 ml Bottles; 500 30 mL bottles)
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.

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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.