People using certain compounded tirzepatide injections are being urged to check their medication after a nationwide recall over concerns about sterility.

A nationwide recall of certain compounded weight-loss injections is raising new questions about medication safety.

Apothecary Pharma LLC voluntarily recalled specific lots of compounded tirzepatide injections after concerns that the products could not be assured to be sterile, according to the U.S. Food and Drug Administration (FDA).

The FDA classified the recall as Class II, meaning exposure to the affected medication could cause temporary or medically reversible health consequences. The agency's classification indicates that the risk of serious harm is considered remote.

The recall applies to specific lots of compounded tirzepatide, not all weight-loss injections or every medication containing the same active ingredient.

Which Weight-Loss Injections Are Affected?

The recalled product is Apothecary Pharma's compounded tirzepatide injection, supplied in 18 mg/mL, 4 mL sterile multidose vials.

Tirzepatide is the active ingredient in the FDA-approved medications Mounjaro and Zepbound. However, the recalled product is a compounded formulation, not the brand-name medication.

The recall covers the following lot numbers and beyond-use dates:

• AP-202622: October 7, 2026
• AP-202623: October 8, 2026
• AP-202624: October 19, 2026
• AP-202625: October 20, 2026
• AP-202627: October 26, 2026
• AP-202628: October 27, 2026
• AP-202629: October 28, 2026
• AP-202630: October 31, 2026
• AP-202631: November 1, 2026
• AP-202632: November 3, 2026
• AP-202633: November 7, 2026
• AP-202634: November 8, 2026
• AP-202635: November 16, 2026
• AP-202636: November 17, 2026
• AP-202637: November 18, 2026
• AP-202638: November 19, 2026
• AP-202639: November 20, 2026
• AP-202640: November 21, 2026
• AP-202641: November 22, 2026
• AP-202642: November 24, 2026
• AP-202643: November 25, 2026
• AP-202644: November 26, 2026

The dates listed are the products' beyond-use dates, not the dates the recall was announced. 

Consumers should check the lot number printed on their vial and contact their prescriber if they are unsure whether their medication is affected.

What Should You Do If You Have a Recalled Vial?

Anyone who has an affected lot should not use it and should contact their prescribing healthcare professional for instructions on handling the medication and arranging an appropriate alternative.

Because the concern involves sterility, the issue is whether the injectable medication can be relied upon to be free of harmful contamination. The recall does not establish that every vial is contaminated.

The FDA classified the recall in October after the company initiated it in September.

What This Means for Patients

The recall is a reminder that patients using compounded injectable medications should know which pharmacy prepared their prescription and how to identify the product's lot number.

People taking FDA-approved brand-name medications should not assume their prescriptions are included in this particular recall. The action concerns specified lots of Apothecary Pharma's compounded tirzepatide.

Patients with questions about their medication should contact their healthcare provider or pharmacist rather than stopping or changing a prescribed treatment without medical guidance.

For additional information, consumers can consult the FDA's official drug recall and compounding safety resources.