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Is Zepbound Available in Vials Yet? A Guide to Formulations

2 min read

As of September 2025, the manufacturer Eli Lilly has made all FDA-approved doses of Zepbound (tirzepatide) available in both single-dose pens and single-dose vials. For patients wondering, 'Is Zepbound available in vials yet?', the answer is yes, offering a new, lower-cost self-pay option.

Quick Summary

Zepbound (tirzepatide) is now supplied as both a single-dose pre-filled pen and a single-dose vial. This article details the available formulations, the distinction from risky compounded versions, and how to access the official vial product.

Key Points

  • Vials Are Available: As of September 2025, official, FDA-approved Zepbound is available in both single-dose pens and single-dose vials.

  • All Dosages: All six strengths of Zepbound, from 2.5 mg to 15 mg, are available in the vial format.

  • Self-Pay Option: Zepbound vials are offered as a lower-cost, self-pay (cash-only) option and are not covered by insurance.

  • Exclusive Channel: Official Zepbound vials can only be purchased through LillyDirect Pharmacy Solutions with a valid prescription.

  • Distinct from Compounded: These FDA-approved single-dose vials are not the same as unapproved, potentially unsafe multi-dose vials from compounding pharmacies.

  • Safety First: The FDA warns against using compounded tirzepatide due to risks of contamination, incorrect ingredients, and dosing errors.

In This Article

Zepbound Formulations: Pens and Now, Vials

Zepbound, containing tirzepatide, is an injectable medication for chronic weight management in certain adults. As of August 2025, Eli Lilly offers all six dosage strengths (2.5 mg to 15 mg) in both the original pen and a single-dose vial format. This vial is intended as a more affordable self-pay option exclusively through LillyDirect Pharmacy Solutions. The medication is the same as in the pen but requires manual administration using a separate syringe and needle.

How to Administer the Zepbound Vial

Administering Zepbound from a vial requires several supplies, including the vial, a syringe and needle (not included), an alcohol swab, and a sharps container. Proper preparation involves washing hands, verifying the medication and dose, and checking the expiration date. The liquid should be clear or slightly yellow without particles. To withdraw the medication, draw air into the syringe equal to your dose (0.5 mL), inject it into the vial, invert the vial, ensure the needle is in the liquid, and draw out the correct dose (0.5 mL). Clean the injection site, pinch the skin, and inject subcutaneously for at least five seconds. Used syringes and needles should be disposed of in a sharps container.

The Critical Difference: FDA-Approved Vials vs. Compounded Tirzepatide

The availability of official Zepbound vials addresses concerns regarding unapproved compounded tirzepatide. The FDA has warned against using compounded GLP-1 drugs like tirzepatide due to safety risks, as they lack FDA review for safety, quality, and effectiveness. Risks include unapproved ingredients, potential contamination, and dosing errors. As of March 2025, the legal basis for compounding tirzepatide has ended because official Zepbound and Mounjaro are no longer on the FDA drug shortage list.

Comparison Table: Zepbound Vial vs. Compounded Vial

A comparison between the FDA-approved single-dose Zepbound vial and an unapproved compounded tirzepatide vial highlights key differences. The FDA-approved vial is manufactured by Eli Lilly and is reviewed for safety and efficacy, containing the approved active ingredient, tirzepatide. It comes as a single-dose format to ensure sterility and dose accuracy and is exclusively available through LillyDirect with a prescription. In contrast, unapproved compounded vials are made by compounding pharmacies without FDA review. They may contain different, unstudied salt forms, are often multi-dose with increased risks of contamination and error, and their availability has been curtailed by FDA action. Compounded products are not subject to rigorous manufacturing controls and carry risks of contamination and unknown side effects.

Conclusion

Yes, Zepbound is available in vials as of late 2025. Eli Lilly offers FDA-approved Zepbound in single-dose vials across all strengths exclusively through LillyDirect as a self-pay option. These official vials are a safe alternative to pens and are distinct from unapproved and risky compounded tirzepatide. Always consult a healthcare provider and source medication from legitimate channels.

For more information on the risks of compounded drugs, please visit the {Link: FDA's official page https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs}.

Frequently Asked Questions

Yes, as of August 2025, all FDA-approved doses of Zepbound (2.5 mg to 15 mg) are available in single-dose vials manufactured by Eli Lilly.

Zepbound vials contain the same FDA-approved medication but require the user to manually draw the dose into a separate syringe and needle for injection. The pens are pre-filled auto-injectors.

Vials sold outside of the official LillyDirect channel are likely unapproved compounded versions. The FDA warns against using these products as they are not reviewed for safety, quality, or effectiveness and may carry significant health risks.

No. Compounded tirzepatide is not FDA-approved and may use different, unverified ingredients (like salt forms) than the official Zepbound product made by Eli Lilly. The FDA has highlighted safety and quality concerns with these compounded versions.

No, the official Zepbound single-dose vials are only available as a self-pay option through LillyDirect and are not eligible for insurance coverage.

Through LillyDirect's self-pay program, the 2.5 mg starter dose is priced at $349 for a month's supply, while the 5 mg through 15 mg doses are priced at $499 per month.

Both medications contain the same active ingredient, tirzepatide, and are made by Eli Lilly. However, Zepbound is FDA-approved for chronic weight management, while Mounjaro is approved for managing type 2 diabetes.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.