Kirkland Severe Cold & Flu Plus Congestion: Day recall
FDA recall D-0115-2025 · initiated Nov 14, 2024
LNK International, Inc. recalled Kirkland Severe Cold & Flu Plus Congestion: Day in Nov 2024 — an FDA Class II recall (D-0115-2025) because CGMP Deviations: Released product should have been rejected.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Released product should have been rejected.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 288 cases x 30 8,640 boxes
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
Frequently asked
- Was Kirkland Severe Cold & Flu Plus Congestion: Day recalled?
- LNK International, Inc. recalled Kirkland Severe Cold & Flu Plus Congestion: Day in Nov 2024 — an FDA Class II recall (D-0115-2025) because CGMP Deviations: Released product should have been rejected. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Kirkland Severe Cold & Flu Plus Congestion: Day recalled?
- Per the FDA enforcement record, the reason for recall D-0115-2025 was: CGMP Deviations: Released product should have been rejected.
- Is a recalled Kirkland Severe Cold & Flu Plus Congestion: Day dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Kirkland Severe Cold & Flu Plus Congestion: Day are affected?
- Distributed: Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.. The recall covers these lots — Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0115-2025.