Severity
Critical
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
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 FDA Drug action (record #D-0456-2023) was formally reported on March 15, 2023, with the manufacturer initiating the action on February 14, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Pharmedica USA, LLC is listed as the recalling firm, operating out of Phoenix, AZ. Federal records list the affected scope as a) 869 bottles; b) 1035 bottles.
The documented reason for this recall is: Non-Sterility Distribution data in the federal record shows the product reached: Nationwide in the USA and Worldwide through e-commerce and trade shows. 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 - 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 - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
a) 869 bottles; b) 1035 bottles
Related Recalls
6
0 from same agency
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
| 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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0456-2023) 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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 15, 2023. 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 July 2026.