Apothecary Pharma is recalling 22 vials of compounded tirzepatide injection nationwide over a lack of assurance of sterility, according to an Oct. 8 FDA notice. Here are four things to know:
- The company began the voluntary recall Sept. 24. The FDA classified it as Class II, which applies to products that may cause temporary or medically reversible health effects when the risk of serious harm is small.
- The recall covers 18 milligrams/milliliter tirzepatide in 4-milliliter sterile multidose vials, lots AP-202622 through AP-202644, with beyond-use dates from Oct. 7 to Nov. 26. Tirzepatide is the active ingredient in Zepbound and Mounjaro.
- The FDA sent Apothecary Pharma a warning letter in December 2025 citing “serious deficiencies” in its practices for making sterile drugs that “put patients at risk.”
- The recall comes amid increased FDA scrutiny of compounded GLP-1s. The FDA has warned of safety and quality concerns as adverse event reports tied to compounded semaglutide and tirzepatide passed 1,700, and in April it proposed excluding semaglutide, tirzepatide and liraglutide from the outsourcing facility bulks list after citing a facility for sterility failures. A federal appeals court sided with the FDA in September in a challenge to its decision that the tirzepatide shortage was over, and compounders are reportedly adding ingredients to sidestep the ban on copying approved drugs.
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