GLP-1 Drug Recalled Nationwide Due To Possible Health Risks

A compounding pharmacy has recalled a GLP-1 drug that was distributed nationwide, according to authorities.

Apothecary Pharma LLC issued the ongoing voluntary recall Sept. 24 for 22 vials of tirzepatide due to “lack of assurance of sterility,” according to the U.S. Food & Drug Administration website. Tirzepatide is the generic name for the drug also known as Mounjaro and Zepbound, per the Mayo Clinic.

The recall was categorized on Oct. 8 as Class II, meaning the recalled items may cause temporary or reversible adverse health consequences, but the probability of serious outcomes is remote, according to the FDA.

Also included in the recall was one vial of NAD+ injection, an anti-aging supplement, per the Cleveland Clinic, which noted NAD is an abbreviation for nicotinamide adenine dinucleotide.

Apothecary Pharma LLC in late 2025 received a warning letter from the FDA’s Center for Drug Evaluation and Research.

In the letter, Office of Compounding Quality and Compliance Director F. Gail Bormel detailed how investigators at the company’s North Carolina facility during the previous May had noted, “serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.”

Issues included difficult-to-clean and visibly rusty equipment or surfaces in production areas, and a failure to disinfect or change gloves frequently enough to prevent contamination, according to Bormel.

“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,” Bormel wrote.

USA Today contacted Apothecary Pharma seeking a comment, but the company did not respond, the newspaper reported.

For more information about the recall, including affected doses and lot numbers, visit the FDA website.