The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1129-2019·Announced 2019-04-24

MSM Nutraceuticals Recalls Dr. Berne's MSM Drops Due to Sterility Concerns

MSM Nutraceuticals is recalling 500 bottles of Dr. Berne's MSM Drops because the product lacks assurance of sterility and was not tested per USP 71.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant safety concerns like sterility assurance in injectable or high-risk dosage forms, even without explicit hospitalization reports in the provided text.

Plain-English summary

MSM Nutraceuticals, LLC is recalling 500 30 mL bottles of Dr. Berne's MSM DROPS 15% Solution. The product is distributed by Dr. Berne's Whole Heallth Products and was sold nationwide in the USA. The specific lot number is 1808051, with an expiration date of 01/01/22.

The recall was initiated because the product is not terminally sterilized and was not tested per USP 71, resulting in a lack of assurance of sterility. This is an FDA Class II recall, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036
Manufacturer
MSM Nutraceuticals, LLC
Category
Drug — Nutraceutical / Supplement
Hazard

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 # 1808051
  • Exp. Date 01/01/22

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by MSM Nutraceuticals, LLC 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 4 products in this recall →

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