Apothecary Pharma is recalling compounded tirzepatide injections distributed nationwide because their sterility cannot be assured.
The recall covers specific lots of 18 mg/mL injections; brand-name Mounjaro and Zepbound are unaffected.
Patients should check their vial labels and contact their pharmacy or prescriber if their medication matches the recalled product.
Apothecary Pharma LLC of Cary, North Carolina, is recalling certain compounded tirzepatide injections because of a “lack of assurance of sterility,” according to the Food and Drug Administration (FDA).
The FDA classified it as Class II on October 8 and included it in its October 14 enforcement report. The agency lists the recalled quantity as 22 vials distributed nationwide.
A Class II designation means a product could cause temporary or medically reversible health problems, or that the likelihood of serious consequences is remote. A lack of sterility assurance does not establish that every affected vial contains contamination, but it raises concerns about whether an injectable medicine is safe to use.
Tirzepatide is the active ingredient in Eli Lilly’s Mounjaro and Zepbound. Those FDA-approved medications are not included in this recall, which concerns a compounded preparation supplied by Apothecary Pharma.
How to identify the recalled medication
The affected product is labeled Tirzepatide Injection, 18 mg/mL, packaged in a 4 mL multidose vial, with National Drug Code 85091-001-18.
Recalled lot numbers run from AP-202622 through AP-202644, excluding AP-202626. Their beyond-use dates range from October 7 through November 26, 2026. These dates indicate how long the preparations were intended to be used, rather than when the recall began. The FDA lists the recall as ongoing.
Patients with an affected vial should stop using that vial and contact their dispensing pharmacy and prescribing clinician for instructions and an appropriate replacement. Those using the medication for diabetes should promptly arrange a treatment plan to avoid an unmanaged interruption in blood sugar control.
Earlier FDA concerns
The recall follows a December 1, 2025, FDA warning letter documenting problems found during an inspection of Apothecary Pharma’s facility that May.
Inspectors described deficiencies in sterile production, including employees obstructing protective airflow over open containers, inadequate glove sanitation, and visibly rusty equipment or surfaces. The FDA said the practices put patients at risk.
The letter acknowledged corrective actions by the company but said some could not be fully evaluated without additional documentation.
What patients should know about compounded drugs
Compounded medications do not undergo the FDA’s review for safety, effectiveness, and quality before being marketed. The agency recommends their use only when a patient’s medical needs cannot be met by an FDA-approved drug.
Consumers should obtain prescriptions from licensed clinicians and use state-licensed pharmacies. Questions about a compounded product’s label or instructions should go to the compounder or telehealth provider that supplied it. Patients can report suspected side effects or medication quality problems through the FDA’s MedWatch program.