A nationwide voluntary recall is underway for tirzepatide injections, the active ingredient behind the widely used diabetes and weight loss drugs Mounjaro and Zepbound.

According to Yahoo, Apothecary Pharma LLC issued the recall of certain lots of its tirzepatide injections over a "lack of assurance of sterility." Per the recall details reported by Yahoo, nearly two dozen lots were sold as 18mg/mL and 4mL sterile multi-dose vials, available by prescription only.

The recall is drawing attention because of how the FDA classified it.

Yahoo reports that the Food and Drug Administration determined the risks associated with the recalled lots as "remote," and assigned the recall a Class II classification, meaning the risks of health consequences are low but not impossible.

Headlines across outlets, including NewsBreak's syndication of the MLive report, have nonetheless described the risk as being raised to the second-highest level, reflecting the Class II designation.

The company did not issue a formal announcement explaining why the recall was issued, which adds to patient uncertainty.

Tirzepatide sits at the center of one of the biggest medication categories in America, and any sterility concern touches people managing diabetes or pursuing weight loss.

According to Yahoo, tirzepatide works by mimicking two hormones the body naturally produces to signal how full you feel and to control blood sugar and hunger.

That mechanism explains why patients on Mounjaro or Zepbound would be alarmed by a sterility flag on injectable vials, where contamination is a distinct hazard.

Because the recalled product was prescription-only and sold in multi-dose vials, patients should contact the pharmacy that dispensed their supply to confirm whether their lot is impacted and arrange a replacement if needed.

As NewsBreak notes, the key question for users is simply how to tell whether their medication is impacted.