OTC Cold and Flu Medication Recalled Due to Manufacturing Process Deviations
LNK International recalls Kirkland Severe Cold & Flu Plus Congestion due to Current Good Manufacturing Practice (CGMP) deviations. The product should not have been released and was distributed to wholesale customers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The manufacturing process deviation is not specifically detailed, making the underlying hazard theoretical. Per the rubric, Class II recalls without reported harm and with unspecified hazards are classified as Moderate.
Plain-English summary
LNK International, Inc. is recalling Kirkland Severe Cold & Flu Plus Congestion due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a Class II recall.
The affected product was manufactured by LNK International, Inc. for Costco Wholesale Corporation. The recall involves two lot numbers: P139953 and P139815, both with expiration dates in August 2026. Approximately 8,640 boxes were distributed to a wholesale retail customer that may have further distributed the product nationwide.
The manufacturer released the product despite manufacturing deviations that should have resulted in the product being rejected. The specific nature of these deviations is not detailed in the recall notice.
Consumers who have purchased this medication should discontinue use and contact Costco for information about returns or refunds.
The recalled product
- Product
- SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL)
- Brand
- SEVERE COLD AND FLU PLUS CONGESTION
- Manufacturer
- LNK International, Inc.
- Category
- Drug — Over-the-Counter
- Hazard
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # P139953
- exp. date 2026/AUG Lot # P139815
- exp. date 2026/AUG
UPCs (1)
- 0196633991997
Distribution
Distributed nationwide across the United States.
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