Who makes Kirkland Signature Extra Strength Acetaminophen 500 mg, 1,000 Caplets?
No reliable public evidence identifies the manufacturer of Kirkland Signature Extra Strength Acetaminophen 500 mg, 1,000 Caplets as of July 5, 2026.
The common claim
What most answers say — and what the evidence supports
Top answers credit LNK International - occasionally Perrigo - as the maker, extrapolating from the fact that LNK International recalled a "Kirkland Severe Cold & Flu Plus Congestion" acetaminophen combo in November 2024. That combo caplet is a different product from the plain Extra Strength 500 mg, and no tier 1-5 source documents who makes the 500 mg caplets, which ship as an FDA over-the-counter monograph drug carrying only Costco Wholesale on the label. Unlike Kirkland's loratadine and ibuprofen - whose FDA drug applications resolve to a named applicant (Perrigo) - a monograph product has no application holder to trace.
Evidence & sources
Costco does not disclose its suppliers, and no tier 1–5 source names the maker of this product. Below is the documented search — every database and record we checked, and what each one returned.
FDA NDC Directory + DailyMed SPL (OTC monograph label route) July 5, 2026
The Extra Strength 500 mg caplets (NDC 63981-700, marketed since 2009) are listed as an OTC Monograph Drug under application identifier M013 - a monograph deemed-drug category, not an ANDA. The DailyMed/SPL record names only Costco Wholesale Company (labeler DUNS 103391843) with no establishment or registrant block, so the deterministic NDC route that identifies a maker for Kirkland's ANDA products names no manufacturer here.
FDA Drugs@FDA (ANDA applicant route) July 5, 2026
M013 is an OTC monograph identifier, not an Abbreviated New Drug Application, and returns no Drugs@FDA sponsor record (query total: none). The applicant route that resolves to Perrigo for Kirkland's loratadine (ANDA076301) and ibuprofen (ANDA072096) does not exist for this monograph acetaminophen - there is no application holder to trace.
FDA drug enforcement / recall database (api.fda.gov) July 5, 2026
One Kirkland acetaminophen recall is on file, and it is a different product: LNK International, Inc. recalled "Kirkland Severe Cold & Flu Plus Congestion" caplets (acetaminophen 325 mg combined with dextromethorphan, guaifenesin, and phenylephrine) on 2024-11-14 (Class II, recall D-0115-2025) for CGMP deviations. That documents LNK as the maker of a Kirkland acetaminophen combo, not the plain Extra Strength 500 mg. LNK also recalled an Extra Strength Acetaminophen 500 mg coated tablet in 2021 (D-0665-2021), but that lot was distributed by AmerisourceBergen (NDC 46122), not Costco. No recall names the maker of the plain Kirkland Extra Strength Acetaminophen 500 mg.
Costco.com product-detail manufacturer field (mfName, via Wayback Machine) July 5, 2026
Costco's newer product pages embed an internal mfName manufacturer field that names real makers on other Kirkland items (PHARMAVITE on fish oil, INTERNATIONAL VITAMIN on the Daily Multi). The only Wayback capture of the Extra Strength Acetaminophen page (item 100213623, snapshot 2025-09-28) is a Wayback shell without the product JSON, and costco.com blocks automated fetch/save, so the mfName field is not retrievable here. Flagged for a manual browser check of the live page.
News and community sweep (Google/Bing news, retailer listings, AI answer boxes) July 5, 2026
No news article, executive statement, or retailer disclosure names the maker of the plain Kirkland Extra Strength Acetaminophen 500 mg. AI answer summaries assert "LNK International," but they extrapolate from the 2024 Kirkland Severe Cold & Flu recall rather than citing a source for this product.
CPSC recall database (SaferProducts.gov) July 5, 2026
OTC drugs fall under FDA jurisdiction, not CPSC; no CPSC record identifies a maker for Kirkland acetaminophen. No other deterministic registry (USDA EST/P-, FDA IMS, TTB, API EOLCS) covers this product.
Frequently asked
Who makes Kirkland Signature Extra Strength Acetaminophen?
Is Kirkland acetaminophen made by the same company as Tylenol?
Was Kirkland acetaminophen ever recalled?
Get notified when a Kirkland manufacturer changes
Suppliers switch quietly and most sites never notice. We track the changes and log the day a maker moves — the same tracking that powers the change log.
Change-log newsletter · no spam · unsubscribe anytime.