CLASS II ONGOING Drug recall · Reported 21 Oct 2026 · FDA Enforcement Report
Tirzepatide/Niacinamide vial (40 MG per Vial) Inj 20mg/2mg/mL recalled
Houston Rx is recalling Tirzepatide/Niacinamide vial (40 MG per Vial) Inj 20mg/2mg/mL, distributed nationwide in the US. The recall was initiated on 25 Sep 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0040-2027
- FDA event ID
- 99990
- Recalling firm
- Houston Rx, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Sep 2026
- FDA classified
- 13 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Diabetes Medication
Timeline
| 25 Sep 2026 | Recall initiated by company | |
| 13 Oct 2026 | Classified by FDA | +18 days |
| 21 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Lack of assurance of sterility.
Which lots are affected?
Lot# TZN-080326-20/2-2, Beyond Use Date: 12/01/2026.
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99990This product is part of a recall event; the main page for the event is Sermorelin, 1 mg/mL vial, Sterile injectable solution recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sermorelin, 1 mg/mL vial, Sterile injectable solution recalled | Houston Rx | Other | Nationwide |
More recalls from Houston Rx
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sermorelin, 1 mg/mL vial, Sterile injectable solution recalled | Houston Rx | Other | Nationwide |
Other Tirzepatide recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tirzepatide 26 MG/ML Injectable recalled by Carolina Infusion | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/cyanocobalamin 76/2 MG/ML Injectable recalled | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/cyanocobalamin 64/2 MG/ML Injectable recalled | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/cyanocobalamin 85/2 MG/ML Injectable recalled | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide Injection, 18mg/mL Sterile Multi-Dose Vial recalled | Apothecary Pharma | Sterility | Nationwide |