K.C. Pharmaceuticals Recalls 74,016 Bottles of Sterile Eye Drops
Summary
K.C. Pharmaceuticals, Inc. initiated a voluntary Class II recall of 74,016 bottles of Rugby brand Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 oz bottles. The recall was initiated on March 3, 2026, due to Lack of Assurance of Sterility. Affected lots are SY24K01 and SY24K02, both expiring 09/30/26. The FDA classified this as a Class II recall on March 31, 2026, and distribution was nationwide in the US.
What changed
K.C. Pharmaceuticals initiated a voluntary Class II recall affecting 74,016 bottles of Rugby Sterile Eye Drops Soothing Tears distributed nationwide. The recall covers two lots (SY24K01 and SY24K02) expiring 09/30/26. FDA classified the recall on March 31, 2026, citing lack of assurance of sterility as the reason.
Healthcare providers, pharmacies, and retailers who received these eye drops should verify their inventory for affected lots and contact K.C. Pharmaceuticals for return instructions. Patients who have purchased this product should consult their healthcare provider if they have concerns. The recall is ongoing and consignees should monitor for updates.
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
K.C. Pharmaceuticals, Inc
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0415-2026 · 20260408 · Ongoing · Voluntary: Firm initiated
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, Liv...
Reason for Recall
Lack of Assurance of Sterility
Affected Lot Numbers / Codes
Lot: a) SY24K01, SY24K02, Exp.: 09/30/26; b) SY24K01, SY24K02, Exp.: 09/30/26.
Quantity
74,016 bottles
Firm Notification Method
Distribution
Nationwide in the US
Initiated
20260303
FDA Classified
20260331
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Source
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Source document text, dates, docket IDs, and authority are extracted directly from K.C. Pharmaceuticals.
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