The Recall Desk
ModerateFDA (Drugs)·D-0033-2024·Announced 2023-10-11

Dr. Berne's MSM Drops Recalled Due to Manufacturing Practice Deviations

Dr. Berne's MSM DROPS is being recalled due to manufacturing practice deviations. The recall involves 6,060 bottles distributed nationwide and internationally.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. It is a voluntary, firm-initiated precautionary recall, and the specific CGMP deviation has not been disclosed. Per the severity rubric, voluntary precautionary recalls without reported harm are classified as Moderate.

Plain-English summary

Dr. Berne's MSM DROPS 15% Solution (30 mL bottles) is subject to a Class II recall initiated on August 26, 2023, by Dr. Berne's Whole Health Products of Tesuque, New Mexico. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process. This is a voluntary, firm-initiated recall.

The recall affects 6,060 bottles distributed nationwide in the United States and internationally to 30 countries including the United Kingdom, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, 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. Multiple lot numbers are affected, with expiration dates ranging from November 2023 through June 2025.

The specific nature of the CGMP deviation has not been disclosed. The product UPC is 00854582001036, and affected lot numbers and their expiration dates are available in the full recall notice.

The recalled product

Product
Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001036
Manufacturer
Dr. Berne's Whole Health Products
Category
Drug
Hazard
  • cgmp-deviation

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 (20)

  • Lots: 6486
  • Exp: 11/23
  • 6536
  • Exp: 01/24
  • 6549
  • Exp: 02/24
  • 6561
  • Exp: 03/24
  • 6623
  • Exp: 06/24
  • 6630
  • 6646
  • Exp: 07/24
  • 6675
  • Exp: 09/24
  • 6686
  • 6695
  • Exp: 10/24
  • 6738
  • Exp: 11/24

Distribution

Distributed nationwide across the United States.