Eli Lilly weight-loss drug tirzepatide recalled by Apothecary Pharma over sterility

Check your medicine cabinet if you use copycat weight-loss treatments. Apothecary Pharma, a compounding pharmacy based in Cary, North Carolina, just recalled 22 sterile multi-dose vials of Compounded tirzepatide, according to an FDA notice. The recall covers 18mg/mL, 4 mL vials and follows a December warning letter from the Food and Drug Administration, the federal agency that regulates drugs, which found serious deficiencies in production practices that put patients at risk.

Apothecary Pharma notified its customers by letter, and the FDA has labeled the action as a Class II recall, signifying a moderate risk of temporary or medically reversible adverse health consequences, though the risk of serious harm is low. Eli Lilly, the massive pharmaceutical company based in Indianapolis, sells the active ingredient as Mounjaro for type 2 diabetes and Zepbound for obesity, with those two blockbuster brands accounting for two-thirds of the company's total revenues in the second quarter of this year.

Eli Lilly previously warned the public against using Compounded versions, stating it does not supply the drug to compounding pharmacies or medical spas, and testing had revealed bacterial contamination and altered chemical structures. The FDA has heightened scrutiny of Compounded incretin therapies following a surge in manufacturing concerns.

Under US law, compounding pharmacies should not sell copycat versions since the drug left shortage lists, though some firms continue providing them under personalization exceptions.

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