Tirzepatide/Niacinamide 2 mL vial Inj 20mg/2mg/mL Recall: Sterility Concern
Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Tirzepatide/Niacinamide 2 mL vial Inj 20mg/2mg/mL recalled?
Lack of assurance of sterility.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
Which lot codes, UPCs or models are affected?
Lot# TZN-080326-20/2-2, Beyond Use Date: 12/01/2026.
- Agency record number
- D-0040-2027
- Product
- Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
- Recalling firm
- Houston Rx LLC
- Quantity
- 64 vials
- Distribution
- Nationwide in the USA.
- Recall started
- September 25, 2026
- Report date
- October 21, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)