CLASS II Drug recall · Reported 18 Dec 2024 · FDA Enforcement Report
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalled
LNK International is recalling Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets, distributed nationwide in the US. The recall was initiated on 14 Nov 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0115-2025
- FDA event ID
- 95773
- Recalling firm
- LNK International, Hauppauge, NY
- Manufacturer
- COSTCO WHOLESALE CORPORATION
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2024
- FDA classified
- 9 Dec 2024
- Reported
- 18 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 14 Nov 2024 | Recall initiated by company | |
| 9 Dec 2024 | Classified by FDA | +25 days |
| 18 Dec 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Released product should have been rejected.
Product as listed by the FDA
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
Where it was distributed
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Stores named: Costco
Questions about this recall
Why was it recalled?
CGMP Deviations: Released product should have been rejected.
Which lots are affected?
Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
Where was it sold?
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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