Kirkland Severe Cold & Flu Plus Congestion: Day — Class II drug recall D-0115-2025
Terminated recall by LNK International, Inc., reported 2024-12-18, distributed nationwide. CGMP Deviations: Released product should have been rejected.
| Recall number | D-0115-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LNK International, Inc., Hauppauge, NY, United States |
| Recall initiated | 2024-11-14 |
| Classified | 2024-12-09 |
| Reported by FDA | 2024-12-18 |
| Terminated | 2025-09-02 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 63981-0795, 63981-0795-81 |
| Lot numbers | 2026/AUG, P139815, P139953 |
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
Reason for recall
CGMP Deviations: Released product should have been rejected.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0115-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.