The Recall Desk
ModerateFDA (Drugs)·D-0036-2024·Announced 2023-10-11

Drug Recall: Dr. Berne's MSM Drops for Manufacturing Practice Violations

Dr. Berne's MSM DROPS 5% Solution is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects 3833 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 an FDA Class II voluntary recall initiated by the firm for CGMP deviations. Without details about specific manufacturing defects or reported adverse events, this precautionary recall warrants a moderate severity rating.

Plain-English summary

Dr. Berne's Whole Health Products is recalling Dr. Berne's MSM DROPS 5% Solution (30 mL/1.014 OZ bottles) due to Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing. The company initiated this voluntary recall on August 26, 2023, and the FDA classified it as a Class II recall on October 4, 2023.

Approximately 3833 bottles with lot numbers 6485, 6562, 6624, 6669, 6688, 6727, 6771, 6830, and 6887 are affected. The product was distributed nationwide and internationally to the UK, 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. Affected bottles have expiration dates ranging from November 2023 to July 2025.

Consumers who have purchased this product should discontinue use and contact Dr. Berne's Whole Health Products for instructions. The company can be reached at [email protected] or at 174 Tesuque Village Rd Unit 458, Tesuque, New Mexico 87574.

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
Affected units
3,833

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 (17)

  • Lot: 6485
  • Exp: 11/23: 6562
  • Exp: 03/24
  • 6624
  • Exp: 06/24
  • 6669
  • Exp: 08/24
  • 6688
  • Exp: 09/24
  • 6727
  • EXP: 11/24
  • 6771
  • Exp: 02/25
  • 6830
  • Exp: 03/25
  • 6887
  • Exp: 07/25.

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 →

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