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, Dextromethorpha

FDA recall notice · announced December 18, 2024 · Lnk

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Lot/code information: Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
Quantity: 288 cases x 30 8,640 boxes
Status: Terminated
Products in this recall event:
- 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 capl (D-0115-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.