Kirkland Signature Severe Cold & Flu Multi-Symptom Caplets Recall Lawsuit | 2026 Latest Updates

Costco has recalled Kirkland Signature Severe Cold & Flu Multi-Symptom Caplets after a lot of the product was found to contain potential foreign material contamination. While no injuries have been reported, consumers who purchased the affected medicine may qualify to pursue compensation for medical costs, replacement expenses, and emotional distress.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

LNK International has recalled two batches of Kirkland Signature Severe Cold & Flu Multi-Symptom Caplets sold at Costco. One lot was pulled January 2, 2025, through Costco, and an earlier lot was pulled November 14, 2024.

The January 2025 recall covers item 1729556 and lot P140082, recalled for potential foreign material contamination. The November 2024 recall covers lots P139953 and P139815, recalled after a manufacturing quality-control deviation. Both recalls remain ongoing.

The January lot went on sale at Costco last fall. No illnesses have been reported. Stop using either lot, and return it to Costco for a refund or discard it.

Recall at a glance
  • Action type: Voluntary recall (two separate recalls, same product line)
  • Announcement and initiation dates: Nov. 14, 2024 (Class II Dec. 9); Jan. 2, 2025
  • Company and responsible agency: LNK International (manufacturer), Costco (retailer); FDA classified Nov. 2024 recall Class II
  • Recall or campaign number: Not stated in the notices
  • Affected models, lots, UPCs, serial numbers, or VINs: Jan. 2025: item 1729556, lot P140082. Nov. 2024: lots P139953, P139815, exp. Aug. 2026.
  • Number of affected units: About 8,640 boxes (Nov. 2024); not published (Jan. 2025)
  • Sold at and sale period: Costco, Midwest/Southeast, Oct. 30-Nov. 30, 2024 (Jan. 2025); nationwide (Nov. 2024)
  • Hazard: Foreign material contamination (Jan. 2025); CGMP deviation (Nov. 2024)
  • Reported incidents, injuries, illnesses, and deaths: No illness or injury reported (Jan. 2025 or Nov. 2024)
  • Remedy: Return to Costco for a full refund, or discard the product

Latest Kirkland Signature Severe Cold & Flu Multi-Symptom Caplets Recall Updates

January 2, 2025: LNK International Recalls Caplets Sold at Costco

LNK International recalled Kirkland Signature Severe Cold & Flu Multi-Symptom Caplets marked lot P140082 and item 1729556, ABC News reported [1]. A rejected lot had reached Costco by mistake, Southern Living reported [2].

LNK International said the affected boxes had reached Costco’s shelves in two regions that fall. The notice told consumers to stop using the product and offered a full refund through Costco.

December 9, 2024: FDA Classifies the November Recall as Class II

The FDA gave the earlier Kirkland recall a Class II rating on December 9, 2024, the middle of three FDA risk levels, for issues unlikely to cause serious harm, Fox News reported [3].

The classification applied to the recall LNK International had already initiated on November 14, 2024, after the product failed a federal manufacturing quality-control review the FDA oversees.

November 14, 2024: FDA Announces Recall over Quality-Control Deviation

The FDA announced a recall of about 8,640 boxes of Kirkland Severe Cold & Flu Plus Congestion Day and Night packs. The affected lots were P139953 and P139815. The cause was a quality-control problem in manufacturing.

The FDA said the product failed to meet Current Good Manufacturing Practice standards and should have been rejected before release, the same Fox News report said. The boxes carried an August 2026 expiration date.

Which Kirkland Signature Severe Cold & Flu Multi-Symptom Caplets Are Affected?

Two separate lots of Kirkland Signature Severe Cold & Flu Multi-Symptom Caplets have been recalled. The affected boxes carry the item numbers and lot codes below, printed on the side of the box near the expiration date:

  • Item 1729556, lot P140082: Sold at Costco stores in the Midwest and Southeast between October 30 and November 30, 2024. Recalled January 2, 2025, for potential foreign material contamination.
  • Lots P139953 and P139815: Kirkland Severe Cold & Flu Plus Congestion packs, expiration August 2026, sold nationwide at Costco. Recalled November 14, 2024, and classified Class II on December 9, 2024.

Consumers who are unsure whether their box is affected should compare the item number and lot code on the packaging against the numbers listed above.

Why Were Kirkland Signature Severe Cold & Flu Multi-Symptom Caplets Recalled?

Kirkland Signature Severe Cold & Flu Multi-Symptom Caplets were recalled because two separate lots failed to meet safety and manufacturing standards.

LNK International pulled the January 2025 lot after a rejected batch reached Costco stores instead of being destroyed, as the company explained when it announced the recall to Costco shoppers.

The earlier, November 2024 recall covered boxes that failed a set of federal rules called Current Good Manufacturing Practice standards. The FDA said the product should have been rejected before it reached stores.

The FDA classified that recall Class II in December 2024, the same middle-risk rating described in the Latest Updates section above.

Reported Incidents, Injuries, or Illnesses

No illness or injury has been reported for either Kirkland Signature Severe Cold & Flu recall.

Supermarket News reported no illnesses tied to the January 2025 lot as of its January 6, 2025 coverage of the recall [4].

No illness or injury report has turned up for the earlier, November 2024 recall either. A report of a problem is not proof that the product caused it.

Consumers who notice a problem after using either lot are encouraged to tell Costco, LNK International, or the FDA, so the reports factor into any future safety review.

Were you or a family member hurt by this product?
Schmidt & Clark offers a free case review for consumers who believe they were harmed after using recalled Kirkland Signature Severe Cold & Flu caplets. A case review is informational only and creates no guarantee of eligibility or of any outcome.

Start My Free Case Review

What Should Consumers Do?

Consumers who have either recalled lot of Kirkland Signature Severe Cold & Flu Multi-Symptom Caplets should take the following steps:

  1. Check the box against the item number and lot codes listed in the product list above, printed near the expiration date, and stop using any caplets that match.
  2. Return the recalled product to a local Costco for a full refund. Consumers may also discard the product, according to ABC7 New York’s coverage of the recall [5].
  3. Consumers can keep taking the medicine from either recalled lot unless LNK International says otherwise, per FDA Class II guidance, and should ask a doctor or pharmacist with any questions [6].
  4. Watch for any unexpected symptoms after taking either lot, contact a doctor or pharmacist with concerns, and report any problem to Costco, LNK International, or the FDA’s MedWatch program. No illnesses have been reported so far.

Schmidt & Clark is looking into possible legal claims tied to the recalled caplets. No lawsuit or class action over either recall had been filed as of the date this page was checked.

A recall does not automatically establish liability or eligibility for compensation. A refund does not by itself change any separate legal options a consumer may have. Only a case review can look at where one person stands.

Filing Deadlines

Deadlines for a product-related legal claim come from state law, not from Schmidt & Clark or from this recall, and they can be easy to miss.

The filing window depends on where the reader lives and on when the alleged harm and any diagnosis occurred. Some states start the clock at diagnosis rather than at the date of use.

Missing a filing deadline can end a claim even when the underlying facts are strong, so anyone weighing legal options after this recall should speak with a lawyer promptly.

Frequently Asked Questions

Is There a Kirkland Signature Severe Cold & Flu Lawsuit?

No lawsuit or class action over the Kirkland Signature Severe Cold & Flu recalls has been filed as of September 25, 2026. If one is filed later, state-law filing deadlines would still apply, so anyone considering a claim should keep records rather than wait for a suit.

Can I Still Use the Product If the Box Is Unopened?

No, you should not still use the product even if the box is unopened. The recall covers the same 168-count twin-pack of 112 daytime and 56 nighttime caplets, whether or not the box has been opened.

Was the Number of Affected Boxes Published for the January 2025 Recall?

No, the number of affected boxes was not published for the January 2025 recall. LNK International’s notice, posted through Costco, identified the recalled product only by its item number and lot code rather than by a total count, unlike the FDA’s November 2024 announcement, which did give a unit total.

Were There Two Separate Kirkland Signature Severe Cold & Flu Recalls?

Yes, two separate Kirkland Signature Severe Cold & Flu recalls happened. LNK International recalled one lot for the contamination issue named above. The FDA had already recalled the same medicine, an 84-dose box that retails for about $15.99, for a manufacturing quality-control deviation about two months earlier.

What Symptoms Should I Watch for After Taking the Recalled Medicine?

Watch for any symptom or reaction after taking either recalled lot of the medicine, and mention it to a doctor or pharmacist. FDA guidance warns that stopping this kind of medicine abruptly is not automatically the safer choice, so raise any unresolved concern with a doctor or pharmacist.

Who Manufactures the Recalled Kirkland Cold and Flu Medicine?

LNK International, Inc. manufactures the recalled Kirkland cold and flu medicine. It is a family-owned drug maker on Long Island, New York. It makes more than 150 over-the-counter formulas for cough, cold, pain relief, and stomach issues, sold under many retail brands, including Costco’s Kirkland Signature line.

References

  1. https://abcnews.go.com/GMA/Wellness/costco-cold-flu-medicine-recalled-due-potential-foreign/story?id=117378885
  2. https://www.southernliving.com/costco-kirkland-cold-flu-medicine-recall-8770536
  3. https://www.foxnews.com/health/costco-brand-cold-flu-medication-recalled-fda-not-effective
  4. https://www.supermarketnews.com/recalls/costco-recalls-kirkland-cold-and-flu-medicine-again
  5. https://abc7ny.com/post/costco-recalls-kirkland-signature-brand-cold-flu-medicine-possible-contamination-can-returned-refund/15749296/
  6. https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do

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