Regulatory Tracker · Non-Commercial Research

Counterfeit GLP-1 Incidents: Regulator Tracker and Data (2023–2026)

This is a regulatory-document tracker, not medical advice. It records what public authorities have formally stated about specific products. It does not estimate prevalence, establish causality, or guide purchasing decisions. Data files: Core CSV · All Records CSV · JSON · XLSX

32
Core regulator notice records
(confirmed or falsified)
12
Issuing authorities across
12 jurisdictions
4
Jurisdictions with insulin
documented in falsified products
24
Core notices with no composition
result published at last check

The dataset behind this tracker was assembled from dedicated public notices issued by drug regulators in 12 countries. Every record met a single binary rule before entering the core count: the issuing authority used the word counterfeit, falsified, or a jurisdictional equivalent with a specific product or presentation. Advisory warnings about general market risk, shortage exploitation without a specific product identification, and spontaneous adverse-event reports were excluded from the core count.

Between May 2, 2023 and July 30, 2026, that rule produced 32 dedicated regulator notice records. Two additional notices described suspected events and are tracked separately. The 32 core records span products including Ozempic, Mounjaro, Rybelsus, and Victoza within a UK multi-brand notice, and in some cases products claiming to be a GLP-1 without a brand assertion. The two suspected notices add detail context in the downloadable dataset but are not added to any headline count on this page.

The tracker does not estimate how often counterfeiting occurs, how many units were affected, or what proportion of the market any record represents. Those estimates require a denominator that does not exist in the public record. This page measures only what regulatory authorities formally disclosed under the inclusion rule.

Key Findings

Table 1. Summary of core dataset findings at dataset version 1.1.0
FindingValueMeaning
Total core records 32 Dedicated regulator notices meeting the confirmed or falsified inclusion rule, May 2023 – July 2026
Suspected-event notices 2 Tracked separately; not added to the 32-record core count
Issuing jurisdictions 12 United States, United Kingdom, Germany, Switzerland, Australia, Brazil, Mexico, Canada, France, Netherlands, Turkey, Singapore
Products in the core record 5 brands + unbranded Ozempic, Mounjaro, Rybelsus, Victoza (in a multi-brand UK notice), Saxenda (in a multi-brand UK notice), unbranded products claiming GLP-1 content
Composition result published 8 of 32 24 core notices did not disclose a composition finding at last verification
Jurisdictions with insulin documented 4 Germany, Switzerland, United Kingdom, Australia
Patient harm documented In at least 4 records Acute hypoglycemia, hospitalization, hypoglycemic shock, life-threatening adverse event
Named lot or serial identifiers At least 7 published PAR1229 (US), D873576 (UK), D881474 (Brazil), and others; see lot table below for full context
EudraVigilance spontaneous reports (semaglutide, potential counterfeit / tampered) 234 Not analytically confirmed products; cannot be added to the 32 core records (see EudraVigilance section)

Source: The RX Index Editorial Team review of primary regulator notices, dataset v1.1.0, verified August 1, 2026.

Chronicle of Major Events

The following table records the most consequential publicly documented events in chronological order. It is not the full 32-record dataset. Dates marked with an asterisk (*) represent the date of the notice or the date the event was publicly identified by the authority, not necessarily the date of manufacture or sale.

Table 2. Chronology of significant publicly documented counterfeit GLP-1 events
Date*JurisdictionAuthorityProductKey finding or actionHarm
May 2, 2023 United States FDA Ozempic First entry in FDA’s rolling counterfeit Ozempic alert. Counterfeit pens identified in the legitimate U.S. drug supply chain. Not stated
2023 (Q3) Australia TGA Ozempic TGA alert: falsified Ozempic with insulin content identified. First Australian regulator record in the dataset. Acute hypoglycemia
2023 (Q3–Q4) Switzerland Swissmedic Ozempic Swissmedic alert: falsified product found to contain insulin glulisine rather than semaglutide. Patient reaction investigated. Acute hypoglycemia; hospitalization
2023 (Q4) United Kingdom MHRA Ozempic 1 mg/1.5 mL MHRA drug alert: falsified Ozempic pens identified. Multiple lot and serial identifiers published, including XA9C10. No semaglutide detected in tested units. Not stated
Dec 21, 2023 United States FDA Ozempic Dated event in FDA rolling alert: counterfeit Ozempic found in the legitimate U.S. supply chain. Lot PAR1229 identified (note: PAR1229 is also a genuine authentic Ozempic lot). Not stated
Early 2024 Germany BfArM Ozempic BfArM alert: falsified Ozempic with insulin documented. Composition analytically established; no patient outcome published in the notice. Not stated in notice
2024 Switzerland Swissmedic Semaglutide product Second Swissmedic record. Hypoglycemic shock documented in associated patient investigation. Hypoglycemic shock
2024 Australia TGA Ozempic TGA urgent warning: falsified Ozempic associated with a life-threatening adverse event. Recall action taken. Life-threatening adverse event
2024 United Kingdom MHRA Mounjaro 15 mg MHRA drug alert: falsified Mounjaro 15 mg pens bearing genuine Mounjaro 7.5 mg batch number D873576. The genuine lot was copied; the pens were not genuine 15 mg Mounjaro. Not stated
2024 United Kingdom MHRA Multi-brand (Ozempic, Saxenda, Victoza) MHRA multi-product drug alert covering multiple GLP-1 and liraglutide brands. Saxenda and Victoza appear as brands in this multi-brand notice only. Not stated
2024 Brazil Anvisa Ozempic Anvisa alert: lot D881474 identified as falsified. Anvisa stated that this action did not apply to other authentic units carrying that lot number. Not stated
Apr 14, 2025 United States FDA Ozempic Dated update in FDA rolling alert. Additional counterfeit Ozempic pens identified. Lots and serials not published in the public notice. Not stated
Dec 5, 2025 United States FDA Ozempic Dated update in FDA rolling alert. Counterfeit Ozempic distributed outside Novo Nordisk’s authorized supply chain. Not stated
2026 (Q1) Mexico COFEPRIS Semaglutide pen COFEPRIS detection: package and pen carried mismatched lots. Laboratory analysis: no semaglutide detected. Contents not fully established at last verification. Not stated

Sources: FDA MedWatch rolling alert; MHRA drug alerts; Swissmedic safety communications; TGA safety alerts; BfArM safety notices; Anvisa alerts; COFEPRIS notices. Individual citations in the Primary Sources section below.

Products and Lot Identifiers

The table below lists every product brand and lot or serial identifier that appeared in a core notice, along with the authority that published it, the date of the notice, and important context. A lot or serial number appearing in a regulator alert does not mean that every unit carrying that number is falsified. In three documented cases, the identified number was also a genuine authentic batch.

Important context before using this table: Do not use a lot number here to draw conclusions about a specific product unit without reading the original regulator notice. FDA confirmed PAR1229 is also used for authentic Ozempic pens. MHRA stated D873576 is a genuine Mounjaro 7.5 mg batch number copied onto falsified 15 mg pens. Anvisa stated D881474 does not apply to other authentic units. Lot numbers are one element of verification, not a standalone test.
Table 3. Published lot, batch, and serial identifiers in core regulator notices
IdentifierProductJurisdictionAuthorityDateStatus publishedContext
PAR1229 Ozempic United States FDA Dec 21, 2023 Counterfeit FDA confirmed PAR1229 is also an authentic Ozempic lot. The presence of this lot number alone does not establish a pen is counterfeit.
XA9C10 Ozempic 1 mg/1.5 mL United Kingdom MHRA 2023 (Q4) Falsified One of the lot/serial identifiers in the MHRA Ozempic drug alert. No semaglutide detected in tested units carrying this identifier.
D873576 Mounjaro 15 mg (falsified) United Kingdom MHRA 2024 Falsified MHRA stated D873576 is a genuine Mounjaro 7.5 mg batch number that was copied onto falsified 15 mg pens. The genuine 7.5 mg batch is not falsified.
D881474 Ozempic Brazil Anvisa 2024 Falsified Anvisa identified specific units under this lot as falsified. Anvisa stated the action did not apply to other authentic units of that lot.
Multiple (not published) Ozempic United States FDA Apr 14, 2025; Dec 5, 2025 Counterfeit FDA’s rolling alert updates referenced additional counterfeits but did not publish specific lot or serial numbers in the public notice.
Mismatched lot pairs Semaglutide pen Mexico COFEPRIS 2026 (Q1) Falsified Package and pen carried different, mismatched lot numbers. No semaglutide detected on laboratory analysis. Specific lot numbers not published in the public notice.
Multiple (not published in notice) Ozempic, Saxenda, Victoza United Kingdom MHRA 2024 Falsified Multi-brand alert. Individual lot identifiers for each product not published in the public summary notice.

Sources: FDA MedWatch; MHRA drug alerts; Anvisa safety notices; COFEPRIS public communications. See Primary Sources section.

Products by record count in the core dataset

Table 4. Core records by product brand (some records cover multiple products)
Product (brand)Active ingredientRecords in core datasetJurisdictions represented
Ozempic Semaglutide 25+ US, UK, Germany, Switzerland, Australia, Brazil, Mexico, Canada, France, Netherlands, Turkey, Singapore
Mounjaro Tirzepatide 1 United Kingdom
Rybelsus Semaglutide (oral) 1 United Kingdom
Victoza Liraglutide 1 (in multi-brand notice) United Kingdom
Saxenda Liraglutide 1 (in multi-brand notice) United Kingdom
Unbranded semaglutide products Claimed semaglutide Included in total Multiple

Source: The RX Index Editorial Team review of primary regulator notices, dataset v1.1.0.

Tested Contents and Documented Harm

Eight of the 32 core notices disclosed a composition finding. The remaining 24 did not publish what was found inside the falsified product, either because testing was not performed, results were not published, or the investigation was ongoing at last verification. The table below covers only the cases where a composition or harm finding was published.

Table 5. Published composition findings and associated documented harm
JurisdictionAuthorityProductPublished contents (tested finding)Documented harm
United Kingdom MHRA Ozempic 1 mg/1.5 mL No semaglutide detected (selected units) Not stated in notice
Germany BfArM Ozempic Insulin (semaglutide absent or not detected) Not stated in notice. Composition established; no patient outcome published.
Switzerland Swissmedic Ozempic Insulin glulisine (semaglutide absent) Acute hypoglycemia; hospitalization
Switzerland Swissmedic Semaglutide product Not published at last verification Hypoglycemic shock
Australia TGA Ozempic Insulin (not semaglutide) Acute hypoglycemia
Australia TGA Ozempic Not published at last verification Life-threatening adverse event
Mexico COFEPRIS Semaglutide pen No semaglutide detected; remaining contents not fully established Not stated
United Kingdom (multiple products) MHRA Insulin (as an active in a falsified GLP-1 presentation) documented in notices citing UK and other EU investigations Insulin documented Not stated in each individual notice

Sources: Swissmedic safety communications; BfArM safety notices; TGA safety alerts; MHRA drug alerts; COFEPRIS notices.

Why insulin matters in a falsified GLP-1: GLP-1 receptor agonists and insulin have opposite dose-response profiles at typical use concentrations. A person using a falsified GLP-1 pen that actually contains insulin is injecting an antidiabetic with a very different mechanism and risk profile, without the dosing context that safe insulin use requires. The documented harms in this record — hypoglycemia, hospitalization, hypoglycemic shock, and a life-threatening adverse event — are consistent with this scenario.

U.S. FDA Rolling Alert Timeline

FDA’s counterfeit Ozempic alert began as a rolling document that was updated as new events were confirmed. The table below reflects the three dated entries in that alert as documented at last verification. This is the public-facing representation of the alert; FDA may hold investigative detail not included in the public notice.

Table 6. Dated events in FDA's rolling counterfeit Ozempic alert
Event dateSummary from FDA alertLot publishedTested contentsHarm stated
May 2, 2023 First entry in rolling alert. Counterfeit Ozempic pens identified in the legitimate U.S. drug supply chain. Not published Not published Not stated
Dec 21, 2023 Counterfeit Ozempic pens found in the legitimate U.S. drug supply chain. Lot PAR1229 cited. FDA noted PAR1229 is also a valid authentic lot number. PAR1229
(also authentic)
Not published Not stated
Apr 14, 2025 Additional counterfeit Ozempic identified. Rolling alert updated. Not published in public notice Not published Not stated
Dec 5, 2025 Counterfeit Ozempic found distributed outside Novo Nordisk’s authorized supply chain. Not published in public notice Not published Not stated

Source: U.S. Food and Drug Administration, MedWatch safety alert: “FDA Alerts Patients and Health Care Professionals about Counterfeit Ozempic (Semaglutide) Found in the United States,” updated through July 2026. fda.gov

EudraVigilance: 234 Spontaneous Reports

The European pharmacovigilance system EudraVigilance contains 234 spontaneous adverse-event reports coded as involving potential counterfeit or tampered semaglutide as of the last check. These reports are not 234 analytically confirmed counterfeit products and are not added to the 32 core records. The distinction matters for interpretation.

Table 7. EudraVigilance reports vs. core regulator notice records: key differences
Dimension234 EudraVigilance reports32 core regulator notice records
Source Spontaneous adverse-event reports submitted by healthcare professionals and patients Formal public notices issued by drug regulatory authorities
What triggers inclusion Voluntary reporter coded the event as involving suspected counterfeit or tampered product Regulator used the word counterfeit, falsified, or equivalent with a specific product or presentation
Analytical confirmation Not required; based on reporter suspicion or observation Required or implied by the authority’s formal notice
Can establish incidence? No. Spontaneous reports reflect a signal, not a count of confirmed events. No. They count disclosed regulatory actions, not all events that occurred.
Can these numbers be added? No. They measure different things. Adding them would inflate an already uncertain count.

Source: EMA EudraVigilance database query for semaglutide adverse events coded as potential counterfeit or tampered product, checked July 2026.

What Counts and What Does Not

The core inclusion rule is intentionally narrow. It distinguishes between a formal determination by a drug regulator and secondary signals, market warnings, or reports that do not rise to the level of a confirmed or formally suspected dedicated notice.

Table 8. Inclusion and exclusion criteria for the core (32-record) count
CategoryIncluded in core count?Rationale
Dedicated regulator notice using “counterfeit,” “falsified,” or jurisdictional equivalent, with a specific product or presentation identified Yes Primary rule. This is the minimum bar for a core record.
Dedicated notices where the authority described the event as “suspected” without analytical or investigative confirmation Tracked separately (2 records) Provides useful context but does not meet the confirmed or falsified bar. Added to the all-records download only.
General market advisory or shortage exploitation warning without a specific identified product No These warn of risk, not a specific confirmed incident. Including them would conflate risk warnings with documented events.
Spontaneous adverse-event reports (EudraVigilance, FDA FAERS, etc.) No Voluntary reports are signals, not confirmed regulatory determinations. The 234 EudraVigilance reports are tracked but not added to the 32.
News articles, social media, or healthcare-provider reports without a corresponding regulator notice No Not independently verifiable against a primary regulatory source.
Unapproved or unregistered GLP-1 products (lacking marketing authorization but not explicitly identified as falsified by a regulator) No An unlicensed product is not automatically falsified. These are a separate category tracked elsewhere.
Compounded GLP-1 products under jurisdiction-specific compounding rules No Compounding is a legally distinct category. A compounded product is not a falsified branded medicine unless a regulator specifically makes that determination.

Source: The RX Index Editorial Team, dataset methodology v1.1.0.

Data Downloads

The full structured dataset is available in three formats below. The core CSV contains only the 32 records meeting the confirmed or falsified inclusion rule. The all-records CSV adds the two suspected-event notices. The JSON file includes the methodology narrative, the exclusion log, and the claim ledger cross-referencing each data point to its primary source.

CSV — Core Records
32 confirmed or falsified records
Download CSV
CSV — All Records
32 core + 2 suspected-event notices
Download CSV
JSON — Complete Dataset
Methodology, exclusions, claim ledger
Download JSON
XLSX — Research Workbook
Full workbook with all tabs
Download XLSX

All files are offered under an open-access, free-to-use basis. Attribution is appreciated but not required for non-commercial research and journalism. Commercial redistribution requires written permission from The RX Index.

Methodology

Source identification

Primary sources are the official websites of drug regulatory authorities in each covered jurisdiction. No secondary reporting was used as a primary source.

Inclusion rule

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.

Cross-border deduplication

When two authorities issued notices about the same physical event, the records are deduplicated and the cross-reference is noted in the JSON claim ledger.

Status classification

Records are classified as Confirmed (authority made a definitive finding), Falsified (authority used the specific WHO/EU falsified-medicine language), or Suspected (authority flagged without analytical confirmation). Only the first two enter the core count.

Composition and harm fields

These fields record 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.

Versioning and update cadence

The dataset is versioned using semantic versioning. Version 1.1.0 was verified on August 1, 2026. The full change history is recorded in the JSON metadata block.

Version history

v1.1.0 — August 1, 2026
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.
v1.0.0 — May 15, 2026
Initial publication of the dataset and tracker page. 29 core records, 11 jurisdictions, dataset verified May 2026.

Frequently Asked Questions

Are there confirmed counterfeit GLP-1 drugs?
Yes. Twelve issuing authorities across 12 jurisdictions have published dedicated records meeting this tracker’s confirmed or falsified inclusion rule. Products in the record include Ozempic, Mounjaro, Rybelsus, Victoza, Saxenda within a multi-brand UK notice, and unbranded products claiming GLP-1 content.
How many counterfeit GLP-1 incidents have been reported?
This tracker contains 32 dedicated regulator notice records meeting its core inclusion rule between May 2, 2023 and July 30, 2026, plus two dedicated suspected-event notices. That is a count of public regulator records, not every incident that occurred worldwide.
What is inside fake Ozempic?
It varies. Documented findings include insulin or insulin glulisine, no semaglutide, and products whose contents were never publicly established. In one 2026 Mexican detection, the package and pen carried mismatched lots and no semaglutide was detected. Twenty-four of the 32 core notices did not publish a composition result at last verification.
Can counterfeit Ozempic contain insulin?
Yes. Regulators in Germany, Switzerland, the United Kingdom and Australia documented insulin in falsified GLP-1 products or packages. Associated records include acute hypoglycemia, hospitalization, hypoglycemic shock and one life-threatening adverse event. The German record established composition but did not state a patient outcome.
Has counterfeit Ozempic entered the U.S. drug supply?
Yes. FDA’s rolling alert contains dated events from December 21, 2023, April 14, 2025 and December 5, 2025 describing counterfeit Ozempic found in the legitimate U.S. drug supply chain and distributed outside Novo Nordisk’s authorized supply chain.
Which Ozempic, Mounjaro, Rybelsus and Victoza lots have been flagged?
The complete table above lists every published identifier with its date, jurisdiction and authority. The list includes copied authentic lots, invalid lots, incompatible serials, mismatched package-and-pen lots and multi-lot alerts. The context matters, so an identifier should not be separated from its serial, strength, market, expiry and physical presentation.
Does a flagged lot number mean every package from that lot is fake?
No. FDA said PAR1229 is also an authentic Ozempic lot, MHRA said D873576 is a genuine Mounjaro 7.5 mg batch number copied onto falsified 15 mg pens, and Anvisa said its D881474 action did not apply to other authentic units of that lot. A flagged number is a reason to check further, not proof about every unit.
How do regulators confirm a counterfeit GLP-1 product?
Methods in the record include laboratory analysis, manufacturer verification of lots and serials, packaging and device inspection, supply-chain or border investigation, seizure analysis, and investigation triggered by patient reactions or product faults. Those methods establish different things and are often used together.
What is the difference between counterfeit, compounded and unapproved GLP-1 drugs?
A falsified medicine deliberately misrepresents its identity, composition or source. Compounding is a separate legal category governed by jurisdiction-specific rules. An unapproved, unlicensed or unregistered product lacks authorization but is not automatically falsified. Only records meeting the tracker’s counterfeit or falsified rule enter the core count.
Are adverse-event reports the same as confirmed counterfeit incidents?
No. The 234 EudraVigilance reports were spontaneous reports coded as involving potential counterfeit or tampered semaglutide. They were not 234 analytically confirmed products, cannot establish incidence and cannot be added to the 32 regulator notice records.
Does this tracker estimate how common counterfeit GLP-1 drugs are?
No. There is no reliable denominator of GLP-1 products in circulation and no complete count of events that never generated a public notice. The tracker measures the disclosed regulator record under a reproducible rule.
When was this dataset last checked?
The included source set was rechecked on August 1, 2026. The corrected dataset is version 1.1.0.

How to Cite This Page

Page citation

The RX Index Editorial Team. “Counterfeit GLP-1 Incidents: Regulator Tracker and Data (2023–2026).” The RX Index. Published August 1, 2026; last verified August 1, 2026. https://therxindex.com/research/counterfeit-glp-1-incidents/

Dataset citation (v1.1.0)

The RX Index Editorial Team. Counterfeit GLP-1 Incidents — Regulator Notice Tracker, v1.1.0. The RX Index, 2026. Dataset. https://therxindex.com/research/counterfeit-glp-1-incidents/

Primary Sources

  1. U.S. Food and Drug Administration. FDA Alerts Patients and Health Care Professionals about Counterfeit Ozempic (Semaglutide) Found in the United States. MedWatch Safety Alert, rolling update. fda.gov
  2. Medicines and Healthcare products Regulatory Agency (MHRA). Drug alerts and recalls: Ozempic (semaglutide). Multiple notices 2023–2026. gov.uk/drug-device-alerts
  3. Medicines and Healthcare products Regulatory Agency (MHRA). Drug alert: falsified Mounjaro (tirzepatide) 15 mg, including lot D873576. 2024. gov.uk/drug-device-alerts
  4. Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM). Falsified Ozempic — insulin content confirmed. Safety notice. 2024. bfarm.de
  5. Swissmedic. Safety communications: falsified semaglutide products with insulin content. Multiple notices 2023–2026. swissmedic.ch
  6. Therapeutic Goods Administration (TGA). Safety alerts: counterfeit Ozempic. Multiple notices 2023–2026. tga.gov.au
  7. Agencia Nacional de Vigilancia Sanitaria (Anvisa). Alerta de falsificacao: Ozempic lote D881474. 2024. gov.br/anvisa
  8. Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS). Alert: falsified semaglutide pen, mismatched lot identifiers. 2026. gob.mx/cofepris
  9. European Medicines Agency. EudraVigilance: adverse-event reports coded as potential counterfeit or tampered semaglutide. Checked July 2026. ema.europa.eu
  10. Health Canada. Drug and health product recalls and advisories: Ozempic (semaglutide). Multiple notices. canada.ca
  11. Agence nationale de securite du medicament et des produits de sante (ANSM). Alertes — Ozempic falsifie. Multiple notices 2024–2026. ansm.sante.fr
  12. Inspectie Gezondheidszorg en Jeugd (IGJ). Geneesmiddelenalerts: Ozempic. Multiple notices. igj.nl

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