FDA recall D-0415-2026

K.C. Pharmaceuticals, Inc · Class II · drug

Product

STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the US

Key facts

Status: Ongoing
Initiation date: 2026-03-03
Report date: 2026-04-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pomona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0415-2026