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Lilly Finds Impurity in Compounded Version of Its Weight-Loss Drug ...

Eli Lilly found a significant impurity in compounded tirzepatide-vitamin B12 products in all tested samples and urged a nationwide recall to prevent potential health risks.

  • On Thursday, Eli Lilly issued a public warning about compounded tirzepatide products mixed with vitamin B12, urging the FDA to initiate a nationwide recall due to identified safety risks.
  • Lilly's testing of compounding pharmacies and telehealth networks found "significant levels of an impurity that results from a chemical reaction between tirzepatide and B12," with effects in humans unknown.
  • The impurity appeared in all ten samples tested by the company. Chief Medical Officer David Hyman warned that adding B12 "without clinical testing or FDA review introduces additional unknown risks."
  • Lilly stated that manufacturers are mixing tirzepatide with glycine and carnitine, calling these "personalizers" a way to circumvent the law and create untested combination drugs.
  • The FDA previously issued warning letters to 30 telehealth companies for misleading claims, and as shortages have ended, the agency is taking "decisive steps" against copycat products.
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WTVB broke the news in on Thursday, March 12, 2026.
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