Tirzepatide/Niacinamide Recalled Due to Lack of Sterility Assurance

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for tirzepatide/niacinamide 2mL/vial. The affected batch has been identified as Lot TZN-080326-20/2-2 (expires December 2026), containing 64 vials.
• The recall was initiated by Houston Rx, LLC due to a lack of assurance of sterility, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Tirzepatide/niacinamide is used to manage metabolic regulation and weight loss.

The FDA has issued a Class II recall for tirzepatide/niacinamide 2mL/vial, affecting 64 vials. This product is being recalled by Houston Rx, LLC based in Houston, Texas. The recall was initiated on September 25, 2026, and received a Class II classification on October 13, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the product’s lack of sterility assurance. This issue affects Lot TZN-080326-20/2-2, which will expire in December 2026. Houston Rx sent out public notices via email, letter, fax, telephone, and personal visit; no press release has been issued for this recall.

Tirzepatide/niacinamide is used for metabolic and weight management among patients with type 2 diabetes and obesity. Pharmacists should identify and quarantine Lot TZN-080326-20/2-2, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 21, 2026. Accessed October 21, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=223081