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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Kirkland Severe Cold & Flu Plus Congestion Recalled for Manufacturing Defects

Agency Publication Date: December 9, 2024
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Summary

LNK International, Inc. is recalling 8,640 boxes of Kirkland Severe Cold & Flu Plus Congestion (Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, and Doxylamine succinate) Day and Night combo packs. The products are being recalled because of manufacturing deviations that occurred during production, meaning products that should have been rejected were instead released for sale. These medications were manufactured specifically for Costco Wholesale Corporation. If you have used this product and have concerns, you should contact your healthcare provider or pharmacist.

Risk

The manufacturer identified deviations in Current Good Manufacturing Practice (CGMP) standards, which means the safety, quality, or purity of the medication cannot be guaranteed. No specific injuries or illnesses have been reported to date, but the medication was released when it should have been held by the factory.

What You Should Do

  1. This recall affects Kirkland Severe Cold & Flu Plus Congestion Day and Night combo packs (NDC 63981-795-81) sold in blister packs containing 112 day caplets and 56 night caplets.
  2. Identify affected products by checking the lot number and expiration date printed on the packaging for lot numbers P139953 or P139815, both with an expiration date of August 2026 (2026/AUG).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact LNK International, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Kirkland Severe Cold & Flu Plus Congestion (Day - 112 caplets / Night - 56 caplets)by Kirkland
Variants: Day and Night Combo Pack, Day: Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg, Night: Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg
Lot Numbers:
P139953 (Exp 2026/AUG)
P139815 (Exp 2026/AUG)
NDC:
63981-795-81

Quantity: 288 cases x 30 (8,640 boxes total). Manufactured for Costco Wholesale Corporation.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95773
Status: Resolved
Manufacturer: LNK International, Inc.
Sold By: Costco Wholesale Corporation
Manufactured In: United States
Units Affected: 288 cases x 30 8,640 boxes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.