{ "dataset": { "name": "Counterfeit GLP-1 Incidents -- Regulator Notice Tracker", "version": "1.1.0", "datePublished": "2026-08-01", "dateModified": "2026-08-01", "dateVerified": "2026-08-01", "temporalCoverage": "2023-05-02/2026-07-30", "creator": "The RX Index Editorial Team", "publisher": "The RX Index (therxindex.com)", "license": "Open access; attribution appreciated for non-commercial research. Commercial redistribution requires written permission.", "description": "A source-bounded dataset of dedicated public regulator notice records concerning confirmed, falsified and suspected counterfeit GLP-1 products from 2023 through July 2026.", "coreRecordCount": 32, "suspectedRecordCount": 2, "totalRecordCount": 34, "jurisdictionCount": 12, "jurisdictions": [ "United States", "United Kingdom", "Germany", "Switzerland", "Australia", "Brazil", "Mexico", "Canada", "France", "Netherlands", "Turkey", "Singapore" ] }, "methodology": { "inclusionRule": "A notice enters the core count only if the issuing authority used 'counterfeit', 'falsified', or a local-language jurisdictional equivalent with a specific product or presentation identified in that notice.", "suspectedRule": "Notices where the authority described the event as 'suspected' without analytical or investigative confirmation are tracked separately and not added to the 32-record core count.", "exclusions": [ "General market advisories or shortage exploitation warnings without a specific identified product", "Spontaneous adverse-event reports (EudraVigilance, FDA FAERS) not tied to a formal regulatory determination", "News articles, social media, or provider reports without a corresponding regulator notice", "Unapproved or unregistered GLP-1 products not explicitly identified as falsified by a regulator", "Compounded GLP-1 products under jurisdiction-specific compounding rules unless explicitly identified as falsified" ], "deduplication": "When two authorities issued notices about the same physical event, records are deduplicated and the cross-reference is noted in this claim ledger.", "statusClassification": { "Confirmed": "Authority made a definitive analytical or investigative finding of counterfeit status", "Falsified": "Authority used WHO or EU falsified-medicine specific language with a product identified", "Suspected": "Authority flagged a product or event without final analytical confirmation" }, "compositionField": "Records only what the authority published. 'Not published at last verification' means the field was absent from the public notice, not that testing was not performed.", "dateField": "Notice date or the date the event was publicly identified by the authority, not the date of manufacture or sale. Dates marked as approximate reflect quarterly-resolution entries where no precise notice date was available in the public record.", "updateCadence": "Dataset is versioned using semantic versioning. The full change history is in the versionHistory block below." }, "claimLedger": { "note": "This ledger cross-references key published claims to their primary sources. It is not exhaustive; the primary sources listed on the tracker page contain the authoritative record.", "claims": [ { "claim": "32 dedicated regulator notice records between May 2, 2023 and July 30, 2026", "source": "The RX Index Editorial Team review of primary regulator notices", "verified": "2026-08-01" }, { "claim": "12 issuing authorities across 12 jurisdictions", "source": "The RX Index Editorial Team review", "verified": "2026-08-01" }, { "claim": "FDA rolling alert: dated event December 21, 2023 -- counterfeit Ozempic in legitimate U.S. supply chain, lot PAR1229 identified. FDA confirmed PAR1229 is also an authentic lot.", "source": "FDA MedWatch: FDA Alerts Patients and Health Care Professionals about Counterfeit Ozempic Found in the United States", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-about-counterfeit-ozempic-semaglutide-found-united", "verified": "2026-08-01" }, { "claim": "FDA rolling alert: dated event April 14, 2025", "source": "FDA MedWatch rolling alert update", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-about-counterfeit-ozempic-semaglutide-found-united", "verified": "2026-08-01" }, { "claim": "FDA rolling alert: dated event December 5, 2025 -- distributed outside Novo Nordisk authorized supply chain", "source": "FDA MedWatch rolling alert update", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-about-counterfeit-ozempic-semaglutide-found-united", "verified": "2026-08-01" }, { "claim": "MHRA: D873576 is a genuine Mounjaro 7.5 mg batch number copied onto falsified 15 mg pens", "source": "MHRA drug alert on falsified Mounjaro", "url": "https://www.gov.uk/drug-device-alerts", "verified": "2026-08-01" }, { "claim": "Anvisa: D881474 action did not apply to other authentic units of that lot", "source": "Anvisa safety notice on Ozempic lot D881474", "url": "https://www.gov.br/anvisa/pt-br", "verified": "2026-08-01" }, { "claim": "Germany (BfArM): falsified Ozempic with insulin documented; composition established; no patient outcome stated in notice", "source": "BfArM safety notice", "url": "https://www.bfarm.de/EN/Home/_node.html", "verified": "2026-08-01" }, { "claim": "Switzerland (Swissmedic): insulin glulisine in falsified Ozempic; acute hypoglycemia and hospitalization documented", "source": "Swissmedic safety communication", "url": "https://www.swissmedic.ch/swissmedic/en/home.html", "verified": "2026-08-01" }, { "claim": "Switzerland (Swissmedic): second record with hypoglycemic shock documented", "source": "Swissmedic safety communication", "url": "https://www.swissmedic.ch/swissmedic/en/home.html", "verified": "2026-08-01" }, { "claim": "Australia (TGA): insulin in falsified Ozempic; acute hypoglycemia documented", "source": "TGA safety alert", "url": "https://www.tga.gov.au/safety/alerts", "verified": "2026-08-01" }, { "claim": "Australia (TGA): life-threatening adverse event documented in a second record", "source": "TGA urgent safety warning", "url": "https://www.tga.gov.au/safety/alerts", "verified": "2026-08-01" }, { "claim": "Mexico (COFEPRIS) 2026: package and pen carried mismatched lots; no semaglutide detected", "source": "COFEPRIS notice", "url": "https://www.gob.mx/cofepris", "verified": "2026-08-01" }, { "claim": "24 of 32 core notices did not publish a composition result at last verification", "source": "The RX Index Editorial Team field-level review of core notices", "verified": "2026-08-01" }, { "claim": "EudraVigilance: 234 spontaneous reports coded as potential counterfeit or tampered semaglutide", "source": "EMA EudraVigilance database query", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/eudravigilance", "verified": "2026-07-01", "note": "These 234 reports are spontaneous adverse-event reports, not analytically confirmed products. They are NOT added to the 32 core regulator notice records." } ] }, "exclusionLog": [ { "type": "Spontaneous adverse-event reports", "description": "234 EudraVigilance reports coded as potential counterfeit or tampered semaglutide", "reason": "Spontaneous reports are signals not confirmed regulatory determinations. Cannot be added to the 32 core records.", "source": "EMA EudraVigilance" }, { "type": "General shortage or market risk advisories", "description": "Multiple regulatory bodies issued general shortage-related warnings advising caution about unverified GLP-1 products without citing a specific confirmed counterfeit product", "reason": "These warn of risk conditions, not specific confirmed incidents. Including them would conflate risk warnings with documented events." }, { "type": "Unapproved or unlicensed products", "description": "Numerous unlicensed semaglutide products were seized or warned about by regulators in multiple jurisdictions", "reason": "An unlicensed product is not automatically falsified. A falsified medicine specifically misrepresents its identity, composition, or source." }, { "type": "Compounded products", "description": "Actions against compounded semaglutide products by FDA, TGA, and others", "reason": "Compounding is a legally distinct category. Compounded products are not in scope unless explicitly identified as falsified branded medicines." } ], "versionHistory": [ { "version": "1.1.0", "date": "2026-08-01", "changes": "Corrected status classification for two records following re-verification against primary source notices. Added three records identified during the July 2026 re-review cycle. Updated temporal coverage end date to 2026-07-30." }, { "version": "1.0.0", "date": "2026-05-15", "changes": "Initial publication. 29 core records, 11 jurisdictions, dataset verified May 2026." } ] }