FDA Drug · D-0115-2025

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

Class II · Terminated

CGMP Deviations: Released product should have been rejected.

Affected lots / codes — check yours against thisLot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG

Recalling firm: LNK International, Inc., Hauppauge, NY
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 288 cases x 30 8,640 boxes
Distribution: Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Recall initiated: November 14, 2024
Classified: December 9, 2024
Terminated: September 2, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0115-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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