Nationwide recall on these compound GLP-1 drugs
The compounded GLP-1s are not FDA-approved nor name-brand.
( NewsNation ) — The FDA has issued a recall for 23 GLP-1 compounded vials from Apothecary Pharma LLC due to lack of assurance the vials are sterile.
The FDA has designated the recall as Class II , meaning exposure to the products could cause reversible or temporary health consequences and poses little risk of serious consequences from use, according to the FDA website.
The recall applies to 22 vials of Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18. Tirzepatide is used in Zepbound and Mounjaro. Customers should look out for these specific codes:
The recall also applies to one vial of NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06. The code information is: Lot #: AP-202647, BUD 13-Oct-2026
Compounding pharmacy flagged by the FDA before
Apothecary Pharma in December 2025 received a letter from the FDA stating, “FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA.”
Apothecary Pharma LLC is a compounding pharmacy in North Carolina. Compounded GLP-1s are not FDA-approved or name-brand. These pharmacies create customized versions of drugs for patients rather than mass-producing them like a commercial pharmacy, and they can adjust medications and create new versions to meet the patient’s specific needs
Although these pharmacies use FDA-approved ingredients, the products themselves are not checked for effectiveness, safety or purity, according to an article in Harvard Health Publishing. The FDA occasionally grants these pharmacies permission to produce drugs in bulk during shortages. In 2022, compounders were given permission to produce their own GLP-1 drugs to fill a shortage at the time. However, tirzepatide and semaglutide were removed from the drug shortage list in late 2024 and early 2025, according to Pharmacy Times reporting. Compound pharmacies continue to produce GLP-1s despite the lack of a shortage.
The FDA has not released official instructions on what to do if you discover you purchased a recalled vial; no illnesses have been linked to the recall at this time. Consumers should stop using it and contact their healthcare provider for guidance.
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