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Counterfeit Ozempic: The Confirmed Lots, and the Tell on the Pen

Two confirmed incidents. Lot PAR0362 with a serial beginning 51746517, and lot PAR1229 identified by the position of the EXP/LOT text on the pen label. Both lot numbers a

Direct answer

Two confirmed incidents. Lot PAR0362 with a serial beginning 51746517, and lot PAR1229 identified by the position of the EXP/LOT text on the pen label. Both lot numbers are genuine — the counterfeit reuses them. And both incidents involved product that reached the legitimate US supply chain, so buying from a licensed pharmacy would not have protected you.

Answer last reviewed: 2026-07-26

The identifiers

Confirmed counterfeit Ozempic incidents
IncidentLot numberHow to identify it Scale
April 2025PAR0362 Counterfeit only when that lot appears with a serial number beginning 51746517. The lot number alone is authenticSeveral hundred units; FDA seized the identified products 9 April 2025
December 2025PAR1229 Position of the EXP/LOT text on the pen label. On the counterfeit it sits to the left of the expiration date and lot number. On an authentic pen it sits above them Dozens of units

Both lot numbers are real. The counterfeiters reused authentic lot numbers, which is why checking the lot alone tells you nothing in either case — you need the serial number or the label geometry.

The exception that most coverage omits

If you used the Patient Assistance Program

Novo Nordisk states that Ozempic 1 mg obtained through its Patient Assistance Program is genuine and not counterfeit, notwithstanding the lot number.

So the same lot number can be authentic or counterfeit depending on how the product was obtained. If you received yours through that programme, the alert does not apply to you.

What was actually counterfeit

Not just the drug. Analysis of the seized products confirmed the needles were counterfeit, so their sterility cannot be confirmed — which the FDA describes as an increased risk of infection.

Also confirmed counterfeit: the pen label, the accompanying healthcare professional and patient information, and the carton.

The FDA and Novo Nordisk have said they could not confirm the identity, quality or safety of the drug inside. That is a more serious statement than it sounds: nobody knows what was in the pen.

What has been reported so far

The FDA is aware of five adverse events from the PAR1229 lot, none serious, and all consistent with known common reactions to authentic Ozempic — nausea, vomiting, diarrhoea, abdominal pain and constipation.

That is reassuring as far as it goes, and it goes only that far. Five reports from dozens of seized units tells you about the reports, not about the contents.

Why the usual advice would not have helped

Almost every article on this subject ends with “buy from a licensed pharmacy”. In both confirmed incidents, the counterfeit product was in the legitimate United States drug supply chain. It reached patients through licensed retail pharmacies.

The advice is still correct as a baseline — it protects you from a much larger category of risk. It simply would not have protected you here, and a page that implies otherwise is giving false comfort.

The FDA's recommendation to pharmacies is more specific and more useful: purchase only through authorised distributors of the manufacturer, and compare product against the published photographs.

What to do if you think you have one

  1. Do not use it. Not the drug and not the needle.
  2. Check the serial number, not just the lot. For the April 2025 incident, the lot alone is authentic; it is the serial beginning 51746517 that identifies the counterfeit.
  3. Check where the EXP/LOT text sits on the pen label — above the dates on an authentic pen, to the left on the December 2025 counterfeit.
  4. Contact the pharmacy that dispensed it and the manufacturer. Both the FDA and Novo Nordisk have asked to hear from patients who find counterfeit product.
  5. Report it to the FDA through MedWatch, its adverse event and product-problem reporting system.
  6. If you have already injected it, contact a clinician. The infection risk from a non-sterile needle is a separate concern from the drug itself.

A counterfeit is not the same thing as a compounded product

These get conflated constantly and they are different categories.

Three different things
WhatLegal statusWho made it
Approved brand productFDA-approved finished drugThe manufacturer, through its authorised supply chain
Compounded preparationNot FDA-approved as a finished product. Lawful when prepared by a licensed pharmacy against a valid prescriptionA licensed compounding pharmacy
CounterfeitIllegal. Falsely presented as the approved productUnknown

A compounded vial that says it is compounded is not a counterfeit, whatever else you think of it. A pen that claims to be Ozempic and is not, is. Our page on what is actually in a compounded GLP-1 covers the separate questions that category raises.

The connected risk the FDA has flagged

Alongside its 2026 warning letters, the FDA published a GLP-1 webpage covering import alerts intended to keep active pharmaceutical ingredients with quality concerns out of the United States, counterfeit versions of brand-name GLP-1s, and adverse event reporting. The enforcement record sets out the rest.

The through-line is supply provenance. Whether the question is a counterfeit pen, an unnamed compounding pharmacy or an imported active ingredient, it is the same question: who made this, and can you check them? That is why our disclosure register asks the one question it asks.

Medical noteThis page reproduces published FDA and manufacturer identifiers so you can check a product you already hold. It is not medical advice. If you have used a product you believe to be counterfeit, contact a clinician.
FDA docket 2026-08552 — status nowEvaluated 2026-07-26
FDA docket 2026-08552 — status now
FieldDetail
StatusOpen Verified
Time remaining4 days remain. Comments must be submitted by 2026-07-30. Anyone may comment: patients, clinicians, pharmacies and the public. Late filings are not considered.
What is proposedExcluding semaglutide, tirzepatide and liraglutide from the 503B Bulks List, on a finding of no clinical need
Notice91 FR 23431, published 1 May 2026
Original deadline29 to 30 June 2026, a 60-day period
Extended deadline2026-07-30, following a request for a 60-day extension
Who it binds503B outsourcing facilities. Section 503A patient-specific compounding is a separate pathway and is not addressed
Shortage pathwayUnchanged: 503B facilities may still compound during a declared shortage
How to commentThrough the federal docket, or in writing to the contact of record at CDER
Contact of recordTracy Rupp, Center for Drug Evaluation and Research, [email protected]
This block recomputes its own status at every build rather than asserting a state that goes stale. The deadline was extended once already, so treat it as the current position rather than a final one.
The thirteen gates a page clears before it publishes
1Search intent matchDoes the page answer the question actually being asked?2Original value testWhat exists here that is not already on ten other sites?3Source and evidence reviewEvery claim resolves to a ledger entry with a capture date.4Medical reviewA named clinician checks claims against their primary sources.5Pricing verificationFigures re-captured from the provider's own page, dated.6Conflict-of-interest reviewAny relationship that could bias the page, declared.7Legal and regulatory languageNo implied approval, no generic claim, no individual advice.8Accessibility reviewWCAG 2.2 AA, keyboard, contrast, chart data tables.9Mobile QA390px viewport hides no fee, qualifier, status or date.10Structured-data validationJSON-LD matches what a reader can see.11Internal-link validationParent hub, methodology, siblings, tool or dataset.12Duplication and cannibalisation checkNo two pages chasing the same intent.13Date and cadence assignmentReview dates set from real work, not from the calendar.
Show this figure as a table
Data table
StepStageWhat happens
1Search intent matchDoes the page answer the question actually being asked?
2Original value testWhat exists here that is not already on ten other sites?
3Source and evidence reviewEvery claim resolves to a ledger entry with a capture date.
4Medical reviewA named clinician checks claims against their primary sources.
5Pricing verificationFigures re-captured from the provider's own page, dated.
6Conflict-of-interest reviewAny relationship that could bias the page, declared.
7Legal and regulatory languageNo implied approval, no generic claim, no individual advice.
8Accessibility reviewWCAG 2.2 AA, keyboard, contrast, chart data tables.
9Mobile QA390px viewport hides no fee, qualifier, status or date.
10Structured-data validationJSON-LD matches what a reader can see.
11Internal-link validationParent hub, methodology, siblings, tool or dataset.
12Duplication and cannibalisation checkNo two pages chasing the same intent.
13Date and cadence assignmentReview dates set from real work, not from the calendar.
A draft that fails one gate does not publish partially. It waits.
What each step actually changedPrimary sources · captured 2026-07-26
What each step actually changed
DateWhat happenedEffect on compounded access
2022Tirzepatide added to the FDA drug shortage listA shortage listing is what permitted compounders to make copies of the approved product.
2024-10FDA declared the tirzepatide shortage resolvedRemoving the shortage listing removed one of the two legal pathways for compounding tirzepatide.
2025-02FDA declared the semaglutide shortage resolvedThe same pathway closed for semaglutide four months later.
2025-09-16FDA issued 55+ warning letters to online GLP-1 sellersLetters cited misleading direct-to-consumer advertising of compounded GLP-1 products.
2026-02-09Novo Nordisk sued Hims & Hers over compounded semaglutidePatent infringement claim following the launch of a low-cost compounded oral product.
2026-03-03FDA released 30 further warning letters to telehealth firmsTargeting claims that compounded GLP-1s are equivalent to the branded products.
2026-03-09Hims & Hers settled with Novo Nordisk and pivoted to branded supplyHims agreed to offer branded semaglutide and cease most compounded GLP-1 marketing. The largest compounded seller in the category left it. This changes who is actually in the compounded market.
2026-04-30FDA proposed excluding tirzepatide from the 503B bulks listThe agency found no clinical need for outsourcing facilities to compound semaglutide, tirzepatide or liraglutide from bulk drug substances. This proposal targets the second and last remaining pathway.
2026-05-01Formal notice published at 91 Fed. Reg. 23431Docket 2026-08552 sets out the agency's substance-by-substance reasoning.
2026-06-26Comment period extended to 30 July 2026FDA granted an extension after a request for more time to respond. Comments inform, but do not bind, the final determination.
2026-07-30Comment period closesAfter this date the agency considers submissions before making a final determination. No final determination had published as of 24 July 2026.
A proposal is not a final rule. Nothing here says compounded tirzepatide is unlawful today.
503A pharmacy against 503B outsourcing facilityStatutory distinction · pending legal review
503A pharmacy against 503B outsourcing facility
Requirement503A compounding pharmacy503B outsourcing facility
Compounds pursuant toA prescription for an identified individual patientMay compound without patient-specific prescriptions
FDA registrationNot registered as an outsourcing facilityRegisters with FDA
CGMP requirementsNot required to meet CGMPMust comply with CGMP — though registration alone is not evidence of compliance
Primary oversightState board of pharmacyFDA, on a risk-based inspection schedule
Adverse-event reportingNot required under 503ARequired to report adverse events to FDA
Product approval statusNot an FDA-approved productNot an FDA-approved product
What registration establishesNot applicableFDA received the required information, nothing more Verified
Neither route produces an FDA-approved medicine. Registration and inspection are not approval, and no accreditation changes that.

Questions readers actually ask

How do I know if my Ozempic is counterfeit?

Two confirmed incidents. Lot PAR0362 is counterfeit only when paired with a serial number beginning 51746517. Lot PAR1229 is identified by the EXP/LOT text sitting to the left of the dates on the pen label rather than above them.

Is lot PAR0362 or PAR1229 always fake?

No. Both are authentic lot numbers that counterfeiters reused. For PAR0362 you need the serial number; for PAR1229 the label geometry. Product from Novo Nordisk's Patient Assistance Program is genuine regardless.

Were the counterfeits sold by unlicensed sellers?

No. In both confirmed incidents the product had entered the legitimate US drug supply chain and reached patients through licensed retail pharmacies.

What was found in the counterfeit products?

The needles, pen label, patient information and carton were all confirmed counterfeit. The FDA and Novo Nordisk have said they could not confirm the identity, quality or safety of the drug itself.

Is compounded semaglutide counterfeit?

No. A compounded preparation is not FDA-approved as a finished product but is lawful when prepared by a licensed pharmacy against a valid prescription. A counterfeit falsely presents itself as the approved drug.

Cite this pageCC BY 4.0

Tirzepatide Ranked. “Counterfeit Ozempic: The Confirmed Lots, and the Tell on the Pen.” S.J Partners LLC, 2026-07-26. https://tirzepatideranked.com/counterfeit-glp1/

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