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Class II · ModerateRecall completed

Severe Cold And Flu Plus Congestion

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
Where it was soldProduct was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: Released product should have been rejected.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLNK International, Inc. FOR: Costco Wholesale Corporation
Brand nameSEVERE COLD AND FLU PLUS CONGESTION
Generic nameACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL
Distributed by / forLNK International, Inc.
NDC63981-795-81
Show the full FDA record
Full product labelKirkland 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
Recalling firmLNK International, Inc.
DistributionProduct was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Quantity288 cases x 30 8,640 boxes
Recall initiated2024-11-14
Report date2024-12-18
Recall completed2025-09-02
Recall numberD-0115-2025
ClassificationClass II
FDA statusTerminated
Origin on fileHauppauge NY United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.