The Recall Desk
SevereFDA (Drugs)·D-0456-2023·Announced 2023-03-15

Drug Recall: Pharmedica Non-Sterile MSM Drops Due to Contamination

Pharmedica USA recalled Purely Soothing 15% MSM Drops nationwide due to non-sterility concerns. The voluntary Class I recall affects approximately 1,904 bottles distributed via e-commerce and trade shows.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall classification mandates a minimum severity score of 4. While no illnesses have been reported, non-sterility in pharmaceutical products represents a serious potential contamination risk that warranted FDA's Class I designation.

Plain-English summary

Pharmedica USA, LLC has recalled Purely Soothing 15% MSM Drops due to non-sterility concerns. The recall affects two package sizes: 869 bottles of 15 ml (.5 fl oz) with UPC 7 31034 91382 9 (Lot #1808051, Exp. 01/01/2027) and 1,035 bottles of 30 ml (1.014 fl oz) with UPC 7 31034 91379 9 (Lot #2203PS01, Exp. 01/01/2027).

The product was recalled due to non-sterility, which creates a risk of microbial contamination. This is classified as a Class I recall, indicating the FDA's determination that there is a serious potential health risk.

The affected product was distributed nationwide in the USA and worldwide through e-commerce platforms and trade shows. The company initiated the recall voluntarily on February 14, 2023, and the FDA confirmed the classification on March 10, 2023.

Consumers who have purchased Purely Soothing 15% MSM Drops should stop using the product immediately. Anyone who has used the product and has concerns about their health should contact their healthcare provider.

The recalled product

Product
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.
Manufacturer
Pharmedica USA, LLC
Category
Drug
Hazard
  • non-sterility
  • infection-risk

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 (3)

  • Lot #s: a) 1808051
  • Exp.: 01/01/2027
  • b) 2203PS01

Distribution

Distributed nationwide across the United States.