Q: What should med spas tell patients asking about the compounded tirzepatide recall?

What to tell patients about the Apothecary Pharma recall

A:Med spas should tell patients whether their tirzepatide came from the recalled Apothecary Pharma lots, since branded Mounjaro and Zepbound are unaffected and the recall covers 22 vials of compounded tirzepatide.¹ A compounded drug is a medication that a compounding pharmacy mixes from drug ingredients to tailor it for a patient who might benefit from a customized version.²

The FDA classified the recall as Class II, which applies to products that may cause temporary or medically reversible health effects, where the risk of serious harm is small. The recall rests on sterility that cannot be assured, and the FDA notice listed zero illnesses or injuries linked to the recalled products. AmSpa advises practices to find affected patients through dispensing and administration records and to follow the medical director's protocols for patient outreach.¹

For more about what the FDA has found on compounded tirzepatide, see our compounded injectable risk. USA TODAY reports that an Oct. 1 FDA notice lists marketers who claim compounded drugs are the same as the FDA-approved version among its red flags. Erin Fox of University of Utah Health told USA TODAY that patients should understand why they need a compounded version, and that choosing one just for price is buyer beware.²