FDA Drugs recall ·
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets… recall
- Recall number
- D-0115-2025
- Date
- (initiated November 14, 2024)
- Company / brand
- LNK International, Inc.
22 Arkay Dr, Hauppauge, NY, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 288 cases x 30 8,640 boxes
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
CGMP Deviations: Released product should have been rejected.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
Distribution
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0115-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.