Class I Recall for Contaminated Eye Drops

A Class I recall has been issued for 1,904 bottles of Purely Soothing 15% MSM Drops due to non-sterility of the product, according to the March 15, 2023, US Food and Drug Administration (FDA) Enforcement Report. The most serious designation, a Class I recall warns use of the affected medication could cause serious adverse health consequences or death.

“Use of contaminated eye drops can result in the risk of eye infections that could result in blindness,” maker Pharmedica USA stated in a March 3, 2023, company announcement. “To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product.”

The recall affects the following products, which were manufactured by Pharmedica USA, Phoenix, Arizona, and distributed throughout the United States and worldwide through e-commerce and trade shows:

• Purely Soothing 15% MSM Drops, 15-ml (5 fl oz) bottles (UPC 7 31034 91382 9), from lot 1808051 (Exp. 1/1/27); and
• Purely Soothing 15% MSM Drops, 30-ml (1.014 fl oz) bottles (UPC 7 31034 91379 9), from lot 2203PS01 (Exp. 1/1/27). 

Pharmedica USA voluntarily initiated the recall February 14, 2023. The FDA designated the recall Class I on March 10, 2023. 

Purely Soothing 15% MSM Drops are used as an anti-inflammatory for symptoms of ocular irritation and swelling.