Agency classClass IIOur severity:High FDA (Drugs)·D-0415-2026·Announced 2026-04-08

Rugby and Walgreens lubricant eye drops recalled over sterility assurance

K.C. Pharmaceuticals is recalling Sterile Eye Drops Soothing Tears, sold as Rugby Lubricating Eye Drops and Walgreens Lubricant Eye Drops, for lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a sterile ophthalmic product whose sterility cannot be assured, with no injuries stated.

Plain-English summary

K.C. Pharmaceuticals, Inc is recalling Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%) in 0.5 fl oz (15 mL) bottles, sold as Rugby Lubricating Eye Drops (NDC 0536-1219-94) and Walgreens Lubricant Eye Drops (UPC 311917203003). About 74,016 bottles were distributed nationwide in the United States. The FDA has classified this recall as Class II.

The recall was initiated for lack of assurance of sterility.

Affected product covers lots SY24K01 and SY24K02, both with an expiry date of 09/30/26, across both brands.

Consumers and pharmacies can identify affected product by the NDC or UPC and lot numbers above, and may contact K.C. Pharmaceuticals, Inc for further information.

The recalled product

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…
Manufacturer: K.C. Pharmaceuticals, Inc
Category: Drug — Ophthalmic
Hazard: sterility-failure
infection-risk
Affected units: 74,016

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by K.C. Pharmaceuticals, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · K.C. Pharmaceuticals, Inc

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Same hazard · sterility failure