Why it was recalled
CGMP Deviations: Released product should have been rejected.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
Where it was sold
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0115-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 14, 2024
- FDA report date
- Dec 18, 2024
- Quantity
- 288 cases x 30 8,640 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LNK International, Inc.
Original FDA data
Every field from FDA enforcement report D-0115-2025, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 95773
- Address
- 22 Arkay Dr
- Code information
- Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
- Postal code
- 11788-3708
- Report date
- Dec 18, 2024
- Product type
- Drugs
- Recall number
- D-0115-2025
- Classification
- Class II
- Recalling firm
- LNK International, Inc.
- Product quantity
- 288 cases x 30 8,640 boxes
- Termination date
- Sep 2, 2025
- Reason for recall
- CGMP Deviations: Released product should have been rejected.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
- Recall initiation date
- Nov 14, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 9, 2024