← FDA ENFORCEMENT
D-0415-2026Class II

K.C. Pharmaceuticals, Inc

Recalling firm
K.C. Pharmaceuticals, Inc
Product type
Drug
Status
Ongoing
Report date
2026-04-08
Distribution
Nationwide in the US
Firm state
CA
Product quantity
74,016 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.