FDA Recall D-0415-2026

K.C. Pharmaceuticals, Inc · Pomona, CA

Class II Ongoing 72 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

Quantity: 74,016 bottles

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0415-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the US
Recall initiated: 2026-03-03
Classified by FDA Center: 2026-03-31
FDA published: 2026-04-08
Recalling firm: K.C. Pharmaceuticals, Inc
Firm location: Pomona, CA

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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