Agency classClass IOur severity:Critical FDA (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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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.

Part of a larger recall action

This product is one of 5 recalled by Dr. Berne's Whole Health Products under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Dr. Berne's Whole Health Products

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Same hazard · non sterility