Recalls / Class II
Class IID-0115-2025
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
- Brand name
- Severe Cold And Flu Plus Congestion
- Generic name
- Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Guaifenesin, Phenylephrine Hcl
- NDC
- 63981-795
- FDA application
- M012
- Affected lot / code info
- Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
Why it was recalled
CGMP Deviations: Released product should have been rejected.
Recalling firm
- Firm
- LNK International, Inc.
- Manufacturer
- COSTCO WHOLESALE CORPORATION
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 22 Arkay Dr, Hauppauge, New York 11788-3708
Distribution
- Quantity
- 288 cases x 30 8,640 boxes
- Distribution pattern
- Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Timeline
- Recall initiated
- 2024-11-14
- FDA classified
- 2024-12-09
- Posted by FDA
- 2024-12-18
- Terminated
- 2025-09-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0115-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.