FDA Recall Due To Weight Loss Drug Labels Mix Up

It’s remarkable how willing some doctors have been to prescribe diabetes drugs like Ozempic and Wegovy off-label for weight loss. However, some patients have found alternative ways to obtain these medications. This year, there have been several reports of counterfeit versions of these weight loss injectables, with multiple patients hospitalized due to adverse reactions.

The risks don’t end there. This week, the FDA announced the recall of 751 units of tirzepatide on April 20, 2024. Tirzepatide is the active ingredient in diabetes and weight-loss drugs Mounjaro and Zepbound, popular brands in this medication class. A 2021 study in the New England Journal of Medicine suggested that Mounjaro might be superior to semaglutide—used in Ozempic and Wegovy—for controlling blood sugar and potentially appetite and weight loss.

Revive Rx Pharmacy, a Texas-based company, appears to be the manufacturer of the recalled 10-milligram multi-dose tirzepatide vials, along with two-milliliter doses of compounding sterile solution. According to the FDA report, the recall was due to a “label mix-up,” revealing a serious issue: vials labeled as tirzepatide actually contained testosterone cypionate.

Yes, vials labeled as tirzepatide contained testosterone. The FDA reported that the mislabeled drug was distributed nationwide in the USA but did not specify particular regions or organizations. The recalled tirzepatide has the following identifiable details:

  • Lot #: 748127
  • Expiration: 9/24/2024

The FDA has classified this as a Class I recall.

FDA Recall Classifications:

  • Class I Recall: The most severe, issued for products that could cause serious health issues or death.
  • Class II Recall: Involves products that may cause temporary or medically reversible adverse health effects.
  • Class III Recall: For products unlikely to cause health problems but that fail to comply with FDA labeling or manufacturing regulations.

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

  1. Diabetes management: Patients missing out on tirzepatide for diabetes could experience uncontrolled blood sugar levels, leading to serious conditions like diabetic ketoacidosis, cardiovascular disease, nerve damage, and other severe complications.
  2. Unintended hormone exposure: Patients receiving testosterone cypionate instead of tirzepatide might face elevated testosterone effects. Testosterone influences muscle mass, fat distribution, and bone density. Inappropriate use can cause hormonal imbalances, mood swings, increased aggression, skin issues, and changes in sexual function. For those not prescribed testosterone, exposure could lead to severe side effects like cardiovascular issues or liver problems. It is particularly serious for pregnant women or individuals with hormone-sensitive cancers (e.g., breast or prostate cancer). Affected individuals should consult their healthcare provider immediately.
  3. Lack of expected weight loss: This could be frustrating and harmful for patients relying on the medication as part of a weight management plan, potentially causing emotional distress or setbacks in their health goals.

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