FDA recall record

K.C. Pharmaceuticals STERILE EYE DROPS SOOTHING TEARS recall — FDA D-0415-2026

Lack of Assurance of Sterility

Class IIclassification
D-0415-2026official record ID
Apr 8, 2026report date

Recall record at a glance

Official recordD-0415-2026
CategoryDrug Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmK.C. Pharmaceuticals, Inc
Report dateApr 8, 2026
Recall initiation dateMar 3, 2026
Quantity74,016 bottles
LocationPomona, CA, United States

Official product description

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

Why the product was recalled

Lack of Assurance of Sterility

Distribution information

Nationwide in the US

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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