Class IITerminated

Kirkland Severe Cold & Flu Plus Congestion: Day recall

FDA recall D-0115-2025 · initiated Nov 14, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations: Released product should have been rejected.

Details

Product: 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
Recalling company: Lnk Intl Inc
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Initiated: Nov 14, 2024
FDA report date: Dec 18, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0115-2025 ↗

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