The U. S.
Food and Drug Administration has classified a nationwide recall of 22 compounded tirzepatide injection vials made by Apothecary Pharma LLC as a Class II recall over sterility concerns.
The voluntary recall started on September 24, 2026, after the company found it could not assure the sterility of the medication.
The agency updated the recall classification on October 10, 2026, according to an FDA notice.
A Class II designation means exposure to the affected medication could cause temporary or medically reversible adverse health consequences, though the risk of serious harm is considered small.
The recalled product contains tirzepatide, the active ingredient in Zepbound and Mounjaro.
These injections are compounded formulations that have not been approved by the FDA as finished drug products.
Product details and affected lots
The affected product is Apothecary Pharma Tirzepatide Injection, a prescription-only, sterile, multidose vial containing 18 milligrams per milliliter in a 4-milliliter container.
The recall covers 22 lot numbers with beyond-use dates ranging from October 7 through November 26, 2026.
The FDA's original notice cited a lack of assurance of sterility as the reason for the recall, and the agency later assigned the Class II classification.
The FDA had previously raised concerns about the manufacturer's practices.
In December 2025, Apothecary Pharma received a warning letter identifying multiple violations involving the production of medications intended or expected to be sterile.
The warning letter described serious deficiencies in practices for producing sterile drug products, which the agency said put patients at risk.
USA TODAY reported that it contacted Apothecary Pharma and the FDA for comment on October 19, 2026, but neither had responded at the time of publication.
Patients who have medication from an affected lot should not use it and should contact their prescriber for instructions.
The FDA and Apothecary Pharma had not issued a public statement specifying how the recalled vials should be returned or disposed of.
Compounding pharmacies prepare customized medications to meet individual patient needs, including changes to dosage forms or the removal of certain ingredients.
They may also prepare medications during shortages, but compounded formulations do not undergo the same FDA review for safety, effectiveness, and quality as approved drugs.
The FDA authorized compounding of GLP-1 medications during shortages in 2022.
Tirzepatide and semaglutide were subsequently removed from the federal drug shortage list in late 2024 and early 2025, prompting renewed regulatory scrutiny of continued large-scale compounding.
Concerns about sterile drug production have a significant historical precedent.
In 2012, contaminated injections from the New England Compounding Center caused a fungal meningitis outbreak that sickened nearly 800 people and killed 64, according to the source report.
The FDA has also reported concerns involving compounders using unapproved salt forms of ingredients.
Pharmaceutical manufacturers Eli Lilly and Novo Nordisk have pursued legal action against compounding pharmacies to restrict the practice.
