CLASS II ONGOING Drug recall · Reported 5 Nov 2025 · FDA Enforcement Report
Tirzepatide Injection, 27 mg/ (9 mg/mL) Multidose Vial recalled by ProRx
ProRx is recalling Tirzepatide Injection, 27 mg/ (9 mg/mL) Multidose Vial, For Subcutaneous Use, distributed in Texas, Utah. The recall was initiated on 15 Oct 2025 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-0120-2026
- FDA event ID
- 97808
- Recalling firm
- ProRx, Exton, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Oct 2025
- FDA classified
- 27 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Diabetes Medication
Timeline
| 15 Oct 2025 | Recall initiated by company | |
| 27 Oct 2025 | Classified by FDA | +12 days |
| 5 Nov 2025 | Published in enforcement report | +9 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 Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
Where it was distributed
TX and UT
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot PRORX08062025-3
Where was it sold?
TX and UT
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 26 Sep 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
6 other products · FDA event 97808This product is part of a recall event; the main page for the event is Semaglutide Injection, 10 mg/ (2.5 mg/mL) Multidose Vial recalled.
More recalls from ProRx
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Semaglutide Injection, 5 mg/ (2.5 mg/mL) Multidose Vial recalled | ProRx | Sterility | TX, UT |
| Drug | CLASS II | Semaglutide Injection (2.5 mg/mL) Multidose Vial recalled by ProRx | ProRx | Sterility | TX, UT |
| Drug | CLASS II | Semaglutide Injection, 8mg/ (2.5 mg/mL) Multidose Vial recalled by ProRx | ProRx | Sterility | TX, UT |
| Drug | CLASS II | Semaglutide Injection, 2.5mg/ (2.5 mg/mL) Multidose Vial recalled | ProRx | Sterility | TX, UT |
| Drug | CLASS II | Semaglutide Injection, 6mg/ (2.5 mg/mL) Multidose Vial recalled by ProRx | ProRx | Sterility | TX, UT |
Other Tirzepatide recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tirzepatide, 60mg/ for Injection vial lyophilized recalled by GenoGenix | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide 20 mg/ (10/mg/mL) recalled by ProRx | ProRx | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide 60 mg/ (20/mg/mL) recalled by ProRx | ProRx | Sterility | Nationwide |