Who makes Kirkland Signature Severe Cold & Flu Plus Congestion?

CONFIRMED

LNK International

Hauppauge, NY · recalling firm · as of Dec 18, 2024

Sold by Costco under its Kirkland Signature label.

The record

Record Facts FDA · D-0115-2025

Source: FDA Enforcement Report
Date: Dec 18, 2024 (FDA report date)
Filed by: LNK International, Inc., Hauppauge, NY
Quantity: 288 cases x 30 8,640 boxes (FDA, Dec 18, 2024)
Class: Class II
Status: Terminated (when we checked)
Reason: CGMP Deviations: Released product should have been rejected.
Label text: Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81

Public record, linked as published Open the record ↗

Date checked: 2026-10-31. A record shows who made or recalled the product at that time. It does not prove who makes it today, and we never say a store-brand item is “the same” as a name brand unless a record says so.

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What the stamps mean

CONFIRMEDA government record (an FDA, NHTSA or CPSC recall, a court docket or a public company filing) names the company, linked below.

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