FDA Recalls Apothecary Pharma Tirzepatide Injections Nationwide

The U.S. Food and Drug Administration has classified a nationwide recall of compounded tirzepatide injections manufactured by Apothecary Pharma LLC as a Class II recall, citing concerns about sterility. The voluntary recall, initiated Sept. 24 and updated Oct. 10, covers 22 vials that could cause temporary or medically reversible health consequences if used.

According to the FDA notice, the recall stems from a lack of assurance that the injections were sterile. The agency's Class II designation indicates that serious harm is unlikely, although the affected medication may still pose health risks.

The recalled products are compounded versions of tirzepatide, the active ingredient in Zepbound and Mounjaro. Unlike commercially manufactured, FDA-approved medications, compounded formulations are customized by specialized pharmacies and are not individually evaluated by the FDA for safety, effectiveness, and quality before use.

The affected product is Apothecary Pharma Tirzepatide Injection, labeled at 18 mg/mL in 4 mL sterile multidose vials available by prescription only. The 22 recalled lot numbers are AP-202622 through AP-202644, excluding AP-202626.

The listed beyond-use dates range from Oct. 7, 2026, through Nov. 26, 2026. The FDA and Apothecary Pharma had not issued public instructions specifically addressing the return or disposal of affected vials in the information provided by USA TODAY.

Patients who have an affected lot should not use the medication and should contact their prescriber for instructions. USA TODAY reported on Oct. 19 that it had contacted both Apothecary Pharma and the FDA for comment but had not received a response.

The recall follows earlier FDA concerns about the company's manufacturing practices. In December 2025, Apothecary Pharma received a warning letter identifying several violations, including deficiencies in practices intended to ensure that drug products requiring sterility were manufactured safely.

Compounded GLP-1 medications have faced increased federal scrutiny since tirzepatide and semaglutide were removed from the official drug shortage list in late 2024 and early 2025. According to the source report, pharmacies that had produced compounded versions during shortages were expected to scale back that activity, but some continued making the medications, prompting regulatory warnings and legal challenges.

The FDA had allowed compounding pharmacies to produce versions of GLP-1 medications during shortages in 2022. These pharmacies can customize formulations to address specific patient needs, including dosage adjustments or the removal of certain ingredients, but compounded drugs do not undergo the same premarket review as FDA-approved medications.

Sterility concerns have previously led to serious public health consequences. In 2012, contaminated injections from the New England Compounding Center were linked to a fungal meningitis outbreak that sickened nearly 800 people and killed 64, according to the source report.

Regulatory concerns have also included reports of compounders using unapproved salt forms of ingredients in their formulations. Pharmaceutical manufacturers Eli Lilly and Novo Nordisk have pursued legal action against compounding pharmacies to restrict or stop certain practices involving their medications.