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Drug FDA Class II Terminated cGMP deviation

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, Ph

LNK International, Inc. Published Dec 18, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact LNK International, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: Released product should have been rejected.

Affected products (1)

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

SEVERE COLD AND FLU PLUS CONGESTION · 288 cases x 30 8,640 boxes

NDC: 63981-795, 63981-795-81
Lot codes: P139953, P139815
Code info: Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 14, 2024
  2. Published
    Dec 18, 2024
  3. Terminated
    Sep 2, 2025
Recall number
D-0115-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.