The Dangers of Oral Tirzepatide

Tirzepatide, the active ingredient in Mounjaro and Zepbound, has quickly become a breakthrough in the treatment of type 2 diabetes, obesity, and sleep apnea. Its unique mechanism, targeting both GLP-1 and GIP receptors, sets it apart from other metabolic medications.

While the injectable version is FDA-approved, an oral form of tirzepatide has been making waves online, touted as a convenient alternative. This article takes a closer look at the current use of oral tirzepatide, its legal standing, how it’s being obtained, and the safety concerns surrounding this drug.

Is Oral Tirzepatide FDA-Approved?

There is no FDA-approved oral formulation of tirzepatide. Despite what some online ads may claim, such as tirzepatide drops, tirzepatide sublinguals, or tirzepatide tablets, none of these forms are approved by the FDA.

Making a drug like tirzepatide in oral form is actually challenging. Tirzepatide is a peptide-based medication, and it needs to enter your bloodstream to be effective. If taken by mouth, it can be broken down by stomach acid, digested by enzymes, and degraded by gut bacteria before it has a chance to work.

Even if it survives this harsh digestive environment, tirzepatide doesn’t pass easily through the lining of the digestive tract, limiting absorption into the bloodstream.

Currently, the only safe and legal way to use tirzepatide is through prescribed subcutaneous injections, delivered just under the skin.

Who Makes FDA-Approved Tirzepatide?

The only legally approved tirzepatide drugs in the US are Mounjaro (for type 2 diabetes) and Zepbound (for weight loss). Eli Lilly is the only company allowed to manufacture tirzepatide for medical use.

They also do not provide tirzepatide to med spas, compounding pharmacies, wellness centers, or websites. So, any other product being sold as “tirzepatide” is not FDA-approved, and its origin is unknown.

Are Compounded Tirzepatide Safe?

Some places mix and sell their own versions of tirzepatide. These are called compounded drugs, and they are not approved by the FDA. According to the FDA, compounded drugs carry higher risks, such as:

• • contamination
  • incorrect dosing
  • fake ingredients

As of April 30, 2025, the FDA had collected 480 reports of adverse events involving compounded tirzepatide.

Eli Lilly has also identified several compounded versions of tirzepatide that were either impure, contaminated with bacteria, or not even the correct drug. In one case, the product was found to be nothing more than sugar alcohol.

Some of these products are labeled “not for human consumption” or “for research use only,” yet are still being promoted for weight loss. These products are also unregulated and unsafe for use. Additionally, some sellers falsely claim their drugs are made in “FDA-approved facilities.” However, the FDA approves products, not manufacturing sites, and making such claims is both misleading and illegal.

Due to reports of harm, Australia banned all compounded versions of tirzepatide in May 2024 after a patient was hospitalized.

In the US, the FDA temporarily allowed certain pharmacies to compound tirzepatide during a shortage of Mounjaro and Zepbound that lasted from late 2022 to early 2025. These temporary permissions have now ended:

• For 503A pharmacies (your typical local or compounding pharmacies), the FDA’s temporary leniency ended on February 11, 2025.
• For 503B outsourcing facilities (larger facilities that make drugs in bulk), the exemption ended on March 19, 2025.

As a result, most tirzepatide compounding is now legally restricted. Any non-FDA-approved version, especially those offered as oral tablets, sublingual drops, or nasal sprays, is not allowed under current regulations.

Which Pharmacies and Websites Are Selling Unapproved Tirzepatide?

Eli Lilly has taken a firm stand against multiple companies selling unregulated tirzepatide products. In 2023, Eli Lilly filed lawsuits in Florida and Texas federal courts against four compounding pharmacies:

• • Better Life Pharmacy
  • ReviveRX
  • Rx Compound Store
  • Wells Pharmacy Network

They also sued six med spas and wellness centers in Arizona, Florida, Georgia, Minnesota, South Carolina, and Utah for falsely marketing their compounded tirzepatide as “Mounjaro.”

More recently, Eli Lilly has filed lawsuits against four telehealth platforms:

• • Mochi Health
  • Fella Health
  • Willow Health
  • Henry Meds

Some of these companies are allegedly selling formulations never studied or approved, such as oral tablets or drops of tirzepatide. Specifically, Lilly claims Mochi Health’s CEO is not a licensed physician, and the company may be practicing medicine unlawfully.

Mochi Health said its operations follow FDA and pharmacy regulations. Its CEO, Myra Ahmad, confirmed she has a medical degree but is not practicing as a doctor. She insists that prescribing decisions are made by licensed professionals. On the other hand, Fella Health, Willow Health, and Henry Meds have not yet publicly responded.

Like Eli Lilly, Novo Nordisk (maker of Ozempic and Wegovy) is also suing clinics and pharmacies for selling compounded or counterfeit versions of its drugs (semaglutide). In February 2024, Novo even won a court case, getting a permanent injunction against one of the sellers.

Safety Risks of Unregulated Tirzepatide Products

Using tirzepatide from unregulated or unauthorized sources can expose you to several serious health risks:

1. Contamination

Some compounded tirzepatide products have been found to contain bacteria, high levels of impurities, or visible discoloration. These can lead to infections, inflammation, or toxic reactions, especially since tirzepatide is injected under the skin.

2. Incorrect Dosage

Getting the dose wrong can be dangerous. Many unregulated versions have too little or too much tirzepatide, which can cause side effects like nausea, vomiting, or dangerously low blood sugar.

Researchers analyzed reports from late 2003 to early 2024 of accidental overdoses involving GLP-1 drugs (including tirzepatide) submitted to the FDA’s Adverse Event Reporting System (FAERS). They found that there were 3,348 cases of accidental overdose tied to GLP-1 drugs. The researchers believe this may be linked to people seeking out compounded or online versions that don’t come with clear instructions or medical guidance.

3. Fake or Wrong Ingredients

Some of these products don’t contain tirzepatide at all. Instead, they may be filled with sugar alcohols, unknown peptides, or inactive fillers. These can trigger allergic reactions or expose your body to chemicals never meant to be injected.

4. No Clinical Testing

FDA-approved drugs go through years of clinical research to confirm their safety, effectiveness, and long-term impact. Compounded tirzepatide? No human trials. No safety data. No guarantees.

5. Risky Labels

Some of these products are labeled “not for human use” or “for research purposes only”, yet they are being sold for weight loss. These are not pharmaceutical-grade drugs, and using them for injection is high-risk and unsafe.

6. No Medical Oversight

Purchasing tirzepatide through social media, med spas, or unregulated telehealth platforms often means there’s no proper medical evaluation, no prescription, and no follow-up care, increasing the risk of complications being missed or unmanaged.

7. Delayed or Missed Treatment

Using unreliable products could mask symptoms, delay proper treatment, or give a false sense of progress, especially dangerous for those managing type 2 diabetes or obesity-related health conditions.

Where To Get Cheap Tirzepatide

You also have the option to get tirzepatide (Mounjaro or Zepbound) shipped right to your door through Pharma Giant, a trusted Canadian pharmacy partner that offers more affordable prices. Canada has a system in place to keep drug prices fair.

The Patented Medicine Prices Review Board (PMPRB) has regulated medication costs since 1987. It compares drug prices to those in 11 other industrialized countries, including France, Germany, and the UK, to prevent them from being set too high.

Here’s a look at the pricing and savings with Zepbound from Pharma Giant:

Here’s a look at the pricing and savings with Mounjaro Kwikpens from Pharma Giant:

Here’s a look at the pricing and savings with Mounjaro vials from Pharma Giant:

Note: Eli Lilly Canada supplies Mounjaro in two formats. The Mounjaro KwikPen is a multi-dose, single-patient prefilled injection pen. Each pen delivers four weekly doses, so one pen lasts an entire month. Meanwhile, the Mounjaro vial is a single-dose format, meaning each vial contains one full dose. A typical month of treatment requires four vials. However, availability is becoming limited, as most patients and pharmacies have transitioned to the newer KwikPen delivery system.

How to order:

How to ensure safe access from Canada

If you’re planning to order tirzepatide from Canada, make sure you’re doing it safely and legally. Here’s how to protect yourself while saving on your prescription:

• • Verify the pharmacy. Only buy from licensed Canadian pharmacies that require a valid prescription and show trusted verification seals such as CIPA or PharmacyChecker. (Verify a legit Canadian pharmacy )

• • Submit your prescription properly. Avoid any site that offers prescription medicine without asking for your prescription. Always upload or send it through verified channels.

• • Know the rules about buying from Canada. While the FDA technically restricts personal importation of prescription drugs, small orders for personal use are generally permitted at its discretion. (See if buying from Canada is legal )

Buying from verified Canadian pharmacies lets you get the same genuine medication safely at a much lower price.

Bottom line

There is no FDA-approved oral tirzepatide. Products like tirzepatide pills, drops, or sublingual tablets sold online are unregulated and unsafe. Eli Lilly is the only company allowed to make tirzepatide, and it’s available only as an injection under the names Mounjaro and Zepbound.

The FDA no longer allows pharmacies to make their own tirzepatide, and lawsuits have been filed against companies selling illegal versions.

To stay safe, use only FDA-approved tirzepatide from a licensed source. If you’re looking to save money, trusted Canadian pharmacy partners like Pharma Giant offer real Mounjaro and Zepbound at lower prices, with a prescription, proper regulations, and reliable shipping.

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