PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported April 24, 2019

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

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Recall #
D-1129-2019
Affected scope
500 30 mL bottles
Initiated
March 12, 2019
Verify with FDA Drug →
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Msm Nutraceuticals, LLC recalled Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Wh… — a moderate-severity action.

Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Wh… was recalled by Msm Nutraceuticals, LLC in April 24, 2019. Reason: Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.. Check the official notice for the remedy. Verify recall #D-1129-2019 with the FDA Drug before acting.

The recall

Msm Nutraceuticals, LLC issued this moderate-severity FDA Drug recall — Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71..

Moderate
severity level
Class II
classification
April 24, 2019
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1129-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-1129-2019) was formally reported on April 24, 2019, with the manufacturer initiating the action on March 12, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Msm Nutraceuticals, LLC is listed as the recalling firm, operating out of Phoenix, AZ. Federal records list the affected scope as 500 30 mL bottles.

The documented reason for this recall is: Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category — 14,048 drugs & medications recalls on record

-50005001,0001,5002,000 20052009201220152018202120242026 216

Where this recall sits in the database

Severity2366872097High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

500 30 mL bottles

Related Recalls

6

5 from same agency

Product description

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

Reason for recall

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-1129-2019
Date reported April 24, 2019
Date initiated March 12, 2019
Recalling firm Msm Nutraceuticals, LLC
Firm location Phoenix, AZ
Affected scope 500 30 mL bottles
Distribution Nationwide in the USA

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-1129-2019) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting — recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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. Recalled by Msm Nutraceuticals, LLC. Units affected: 500 30 mL bottles.
Why was this product recalled?
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 24, 2019. Severity: Moderate. Recall number: D-1129-2019.
Where was the recalled product distributed?
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1129-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported April 24, 2019.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.