The Recall Desk
CriticalFDA (Drugs)·D-0037-2024·Announced 2023-10-11

FDA Recalls Dr. Berne's MSM Drops Due to Non-Sterility Concerns

Dr. Berne's MSM DROPS 5% Solution was recalled by the FDA for non-sterility issues. Lot 6786, with expiration date March 31, 2025, is distributed nationwide and internationally.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification per the severity rubric indicates a Critical rating. Class I is the highest FDA severity designation, applied when there is a reasonable probability that use of the defective product will cause serious adverse health consequences.

Plain-English summary

Dr. Berne's MSM DROPS 5% Solution, a 30 mL/1.014 OZ bottle product distributed by Dr. Berne's Whole Health Products in Tesuque, New Mexico, has been voluntarily recalled. The FDA classified this as a Class I recall due to non-sterility concerns that create a potential for microbial contamination.

The recall affects Lot 6786 with an expiration date of March 31, 2025. The product was distributed nationwide and internationally, including to the United Kingdom, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, the Netherlands, Ireland, South Korea, Belgium, Norway, Saudi Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, and Barbados.

Consumers who have purchased Dr. Berne's MSM DROPS 5% Solution should check the lot number on their bottle. If the product is Lot 6786, consumers should stop using it immediately and contact Dr. Berne's Whole Health Products at [email protected] or 174 Tesuque Village Rd Unit 458, Tesuque, NM 87574-2030 for instructions on how to proceed.

The recalled product

Product
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111.
Manufacturer
Dr. Berne's Whole Health Products
Category
Drug
Hazard
  • non-sterility
  • microbial-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 6786
  • Exp: 03/31/25

Distribution

Distributed nationwide across the United States.