CGMP Deviations: Released product should have been rejected.
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📍Recalling firmLNK International, Inc.22 Arkay Dr · Hauppauge, NY 11788-3708
✎ GovInfoNow plain-language explainer
LNK International, Inc. is recalling Kirkland Severe Cold & Flu Plus Congestion caplets because of Current Good Manufacturing Practice (CGMP) deviations. The product was released when it should have been rejected during manufacturing. The recall covers specific lots distributed to a wholesale retail customer who may have further distributed the product nationwide. Read more at govinfonow.com/recall/32433-kirkland-severe-cold-flu-recall-cgmp-deviations.
“Kirkland Severe Cold & Flu Recall: CGMP Deviations.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32433-kirkland-severe-cold-flu-recall-cgmp-deviations. Based on FDA recall #D-0115-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0115-2025%22&limit=1).
The FDA announced on Nov. 14, 2024, that LNK International, Inc. is recalling Kirkland Signature Severe Cold & Flu Plus Congestion caplets due to CGMP deviations where released product should have been rejected. The recall affects specific lots distributed nationwide.
How to tell if you have it
Brand: Kirkland Signature
Product: Severe Cold & Flu Plus Congestion Caplets
The recall is due to CGMP deviations where the released product should have been rejected.
Context
LNK International, Inc. has 5 other recalls on record since 2012-07-18. Other recent recalls of similar products include LNK Walgreens Sinus Relief Product Mislabeled as Decongestant-Free (2022-10-11), LNK Nighttime Sleep-Aid Tablets: Incorrect Labeling Risk (2022-08-04), and LNK International Acetaminophen Tablets Recalled for Incorrect Labeling (2021-07-07). Other recent recalls of similar products include Blossom Pharmaceuticals Globe Clotrimazole Cream Recall: Cgmp Deviations (2025-10-31), Wells Pharma Ketamine Injectable Solution Recall: C G M P Deviations (2026-04-01), and Wells Pharma Fentanyl Citrate Injectable Solution Recall: Cgmp Deviations (2026-04-01).
How to tell if you have this one
Check your package for NDC# 63981-795-81. Look for Lot # P139953 with an expiration date of 2026/AUG or Lot # P139815 with an expiration date of 2026/AUG. The product includes Day and Night caplets blister packs.
Brand
Kirkland Signature
Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0115-2025 (November 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0115-2025 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.