Recall alert: Some GLP-1 injections recalled over sterility concerns

Some vials of compounded GLP-1 injections have been recalled because the products may not be sterile, federal health officials said.

According to the U.S. Food and Drug Administration, Apothecary Pharma is recalling 23 vials of the injectable drugs that were distributed nationwide. The voluntary recall includes 22 vials of compounded tirzepatide, a GLP-1 medication containing the same active ingredient as Mounjaro and Zepbound, Fox News reported. The other vial was a NAD+ injection, according to the news outlet.

The Cary, North Carolina-based pharmacy was previously reprimanded by the FDA for “serious deficiencies” in its practices, according to the Los Angeles Times.

Apothecary Pharma first initiated a voluntary recall of tirzepatide injections on Sept. 24 for “lack of assurance of sterility,” USA Today reported, citing an FDA notice.

The FDA elevated the recall on Oct. 10 to Class II status, according to the newspaper. That means that people using the medication could be subjected to “temporary or medically reversible adverse health consequences.” However, the risk of serious harm is small.

Compounded versions of the injections mean that the products were not name brands or approved by the FDA. The injections were custom-formulated, USA Today reported.

According to the recall notice, the affected tirzepatide product is an 18 mg/mL prescription injection in a 4 mL multidose vial, with NDC number 85091-001-18, Fox News reported. Recalled lots are AP-202622 through AP-202625 and AP-202627 through AP-202644, the notice states.

According to USA Today and Fox News, Apothecary Pharma received an FDA warning letter on Dec. 1, 2025, listing several violations, including “serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.”

The FDA and Apothecary Pharma have not issued instructions so far about what to do with the affected vials, USA Today reported.

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