FDA Drug Recalls

Recalls / Class II

Class IID-0415-2026

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

Affected lot / code info
Lot: a) SY24K01, SY24K02, Exp.: 09/30/26; b) SY24K01, SY24K02, Exp.: 09/30/26.

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
K.C. Pharmaceuticals, Inc
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
3420 Pomona Blvd, Pomona, California 91768-3236

Distribution

Quantity
74,016 bottles
Distribution pattern
Nationwide in the US

Timeline

Recall initiated
2026-03-03
FDA classified
2026-03-31
Posted by FDA
2026-04-08
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0415-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.