Evidence review
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
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.
The identifiers
| Incident | Lot number | How to identify it | Scale |
|---|---|---|---|
| April 2025 | PAR0362 |
Counterfeit only when that lot appears with a serial number beginning 51746517. The lot number alone is authentic | Several hundred units; FDA seized the identified products 9 April 2025 |
| December 2025 | PAR1229 |
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
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
- Do not use it. Not the drug and not the needle.
- 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.
- 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.
- 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.
- Report it to the FDA through MedWatch, its adverse event and product-problem reporting system.
- 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.
| What | Legal status | Who made it |
|---|---|---|
| Approved brand product | FDA-approved finished drug | The manufacturer, through its authorised supply chain |
| Compounded preparation | Not FDA-approved as a finished product. Lawful when prepared by a licensed pharmacy against a valid prescription | A licensed compounding pharmacy |
| Counterfeit | Illegal. Falsely presented as the approved product | Unknown |
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.
| Field | Detail |
|---|---|
| Status | Open Verified |
| Time remaining | 4 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 proposed | Excluding semaglutide, tirzepatide and liraglutide from the 503B Bulks List, on a finding of no clinical need |
| Notice | 91 FR 23431, published 1 May 2026 |
| Original deadline | 29 to 30 June 2026, a 60-day period |
| Extended deadline | 2026-07-30, following a request for a 60-day extension |
| Who it binds | 503B outsourcing facilities. Section 503A patient-specific compounding is a separate pathway and is not addressed |
| Shortage pathway | Unchanged: 503B facilities may still compound during a declared shortage |
| How to comment | Through the federal docket, or in writing to the contact of record at CDER |
| Contact of record | Tracy Rupp, Center for Drug Evaluation and Research, compounding@fda.hhs.gov |
Show this figure as a table
| Step | Stage | What happens |
|---|---|---|
| 1 | Search intent match | Does the page answer the question actually being asked? |
| 2 | Original value test | What exists here that is not already on ten other sites? |
| 3 | Source and evidence review | Every claim resolves to a ledger entry with a capture date. |
| 4 | Medical review | A named clinician checks claims against their primary sources. |
| 5 | Pricing verification | Figures re-captured from the provider's own page, dated. |
| 6 | Conflict-of-interest review | Any relationship that could bias the page, declared. |
| 7 | Legal and regulatory language | No implied approval, no generic claim, no individual advice. |
| 8 | Accessibility review | WCAG 2.2 AA, keyboard, contrast, chart data tables. |
| 9 | Mobile QA | 390px viewport hides no fee, qualifier, status or date. |
| 10 | Structured-data validation | JSON-LD matches what a reader can see. |
| 11 | Internal-link validation | Parent hub, methodology, siblings, tool or dataset. |
| 12 | Duplication and cannibalisation check | No two pages chasing the same intent. |
| 13 | Date and cadence assignment | Review dates set from real work, not from the calendar. |
| Date | What happened | Effect on compounded access |
|---|---|---|
| 2022 | Tirzepatide added to the FDA drug shortage list | A shortage listing is what permitted compounders to make copies of the approved product. |
| 2024-10 | FDA declared the tirzepatide shortage resolved | Removing the shortage listing removed one of the two legal pathways for compounding tirzepatide. |
| 2025-02 | FDA declared the semaglutide shortage resolved | The same pathway closed for semaglutide four months later. |
| 2025-09-16 | FDA issued 55+ warning letters to online GLP-1 sellers | Letters cited misleading direct-to-consumer advertising of compounded GLP-1 products. |
| 2026-02-09 | Novo Nordisk sued Hims & Hers over compounded semaglutide | Patent infringement claim following the launch of a low-cost compounded oral product. |
| 2026-03-03 | FDA released 30 further warning letters to telehealth firms | Targeting claims that compounded GLP-1s are equivalent to the branded products. |
| 2026-03-09 | Hims & Hers settled with Novo Nordisk and pivoted to branded supply | Hims 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. |
| 2026-04-30 | FDA proposed excluding tirzepatide from the 503B bulks list | The 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. |
| 2026-05-01 | Formal notice published at 91 Fed. Reg. 23431 | Docket 2026-08552 sets out the agency's substance-by-substance reasoning. |
| 2026-06-26 | Comment period extended to 30 July 2026 | FDA granted an extension after a request for more time to respond. Comments inform, but do not bind, the final determination. |
| 2026-07-30 | Comment period closes | After this date the agency considers submissions before making a final determination. No final determination had published as of 24 July 2026. |
| Requirement | 503A compounding pharmacy | 503B outsourcing facility |
|---|---|---|
| Compounds pursuant to | A prescription for an identified individual patient | May compound without patient-specific prescriptions |
| FDA registration | Not registered as an outsourcing facility | Registers with FDA |
| CGMP requirements | Not required to meet CGMP | Must comply with CGMP — though registration alone is not evidence of compliance |
| Primary oversight | State board of pharmacy | FDA, on a risk-based inspection schedule |
| Adverse-event reporting | Not required under 503A | Required to report adverse events to FDA |
| Product approval status | Not an FDA-approved product | Not an FDA-approved product |
| What registration establishes | Not applicable | FDA received the required information, nothing more Verified |
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.
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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/
When quoting a figure, include the capture date shown beside it rather than the date you read this page. A price without its capture date is not a usable citation.