A Sought-After Weight-Loss & Diabetes Drug Has Been Recalled Nationwide

Updated: Jun. 07, 2024

It appears to be an off-brand version of a coveted injectable—and a doctor cautions the error could have concerning health consequences for users.

It’s remarkable how willing some doctors have been to write scripts for patients to get off-label access to diabetes drugs like Ozempic and Wegovy for the purpose of weight loss. However, in some cases, patients have found their own avenues to get these medications—in fact, this year there have been multiple reports of “counterfeit” versions of these weight loss injectables, with several patients having been hospitalized for reactions.

Interestingly, the level of risk may not stop there. This week, the FDA published a report that 751 units of tirzepatide were recalled on April 20, 2024. Tirzepatide is the generic name and active ingredient for diabetes and weight-loss drugs Mounjaro and Zepbound, which are two common brands among this class of medication. One 2021 study published in the New England Journal of Medicine suggested that Mounjaro may in fact be “superior to semaglutide”—with semaglutide being the active ingredient in competitors like Ozempic and Wegovy—at controlling blood sugar (and presumably perhaps appetite and weight loss, too).

A Texas firm, Revive Rx Pharmacy, appears to be the manufacturer for the 10-milligram multi-dose tirzepatide vials, which have been recalled alongside two millimeter doses of compounding sterile solution. The reason for the recall, according to the FDA report, is a “label mix-up”—and an alarming one: “Product labeled as tirzepatide contains testosterone cypionate.”

That’s right: Vials packaged as tirzepatide actually contain testosterone. The FDA’s report states only that the drug was distributed “USA nationwide,” but not to specific regions or organizations. The recalled tirzepatide bears the following identifiable details:

Lot #: 748127, Expiration 9/24/2024

The FDA has categorized this as a Class I recall.

What Each FDA Recall Classification Means
Class I Recall This is the most severe recall type, issued for products that could cause serious health issues or death.
Class II Recall This type involves products that may cause temporary or medically reversible adverse health effects.
Class III Recall This is for products that are unlikely to cause health problems but fail to comply with FDA labeling or manufacturing regulations.

The Healthy by Reader’s Digest contributor Dr. Tricia Varacallo, DO, lists a few potential health consequences for individuals who unknowingly administer testosterone:

Diabetes management: Patients who should be receiving tirzepatide for diabetes will miss out on their medication, leading to uncontrolled blood sugar levels. Over time, this may result in high blood sugar, or hyperglycemia, which can lead to serious health issues like diabetic ketoacidosis, cardiovascular disease, nerve damage, and other severe complications.

Unintended hormone exposure: Patients mistakenly given testosterone cypionate instead of tirzepatide could experience effects linked to elevated testosterone levels. Testosterone is a hormone that influences many body functions, including muscle mass, fat distribution, and bone density. Inappropriate use can lead to hormonal imbalances, potentially causing mood swings, increased aggression, skin issues, and changes in sexual function. In individuals not prescribed testosterone, such exposure might also risk more severe side effects like cardiovascular issues or liver problems. Unintended hormone exposure could be particularly serious for certain groups like pregnant women or those with hormone-sensitive cancers (like breast or prostate cancer). It’s important for anyone affected to consult their healthcare provider immediately.

Lack of expected weight loss: This could be particularly frustrating and potentially harmful for patients relying on this medication as part of a broader weight management plan, possibly leading to emotional distress or a setback in their health goals.

Revive Rx did not immediately respond to The Healthy‘s request for comment.

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