PlainRecalls
CriticalClass IOngoing

FDA Drug recall · Reported March 15, 2023

Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.

Non-Sterility

Recall #
D-0456-2023
Affected scope
a) 869 bottles; b) 1035 bottles
Initiated
February 14, 2023
Verify with FDA Drug →
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Pharmedica USA, LLC recalled Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9;… - a critical-severity action.

Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9;… was recalled by Pharmedica USA, LLC in March 15, 2023. Reason: Non-Sterility. Check the official notice for the remedy. Verify recall #D-0456-2023 with the FDA Drug before acting.

The recall

Pharmedica USA, LLC issued this critical-severity FDA Drug recall-Non-Sterility.

Critical
severity level
Class I
classification
March 15, 2023
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0456-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 1 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.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,781 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 196
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

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

Product description

Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.

Reason for recall

Non-Sterility

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Ongoing
Recall number D-0456-2023
Date reported March 15, 2023
Date initiated February 14, 2023
Recalling firm Pharmedica USA, LLC
Firm location Phoenix, AZ
Affected scope a) 869 bottles; b) 1035 bottles
Distribution Nationwide in the USA and Worldwide through e-commerce and trade shows

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-0456-2023) 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.
  • This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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?
Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.. Recalled by Pharmedica USA, LLC. Units affected: a) 869 bottles; b) 1035 bottles.
Why was this product recalled?
Non-Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on March 15, 2023. Severity: Critical. Recall number: D-0456-2023.
Where was the recalled product distributed?
Distribution: Nationwide in the USA and Worldwide through e-commerce and trade shows.
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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per … → · All Children & Baby Products recalls

This recall: FDA Drug, reported March 15, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026