CLASS II ONGOING Drug recall · Reported 11 Sep 2024 · FDA Enforcement Report
Tirzepatide 60 mg/ (20/mg/mL) recalled by ProRx
ProRx is recalling Tirzepatide 60 mg/ (20/mg/mL), distributed nationwide in the US. The recall was initiated on 22 Aug 2024 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-0656-2024
- FDA event ID
- 95190
- Recalling firm
- ProRx, Exton, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Aug 2024
- FDA classified
- 5 Sep 2024
- Reported
- 11 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Diabetes Medication
Timeline
| 22 Aug 2024 | Recall initiated by company | |
| 5 Sep 2024 | Classified by FDA | +14 days |
| 11 Sep 2024 | Published in enforcement report | +6 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 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Tirzepatide 60 mg/ (20/mg/mL) recalled?
Yes. ProRx recalled Tirzepatide 60 mg/ (20/mg/mL) on 22 Aug 2024. The recall is Class II and its status is Ongoing. Recall number D-0656-2024.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ProRx
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Semaglutide Injection, 5 mg/ 5 mg/mL) Multidose Vial recalled by ProRx | ProRx | Sterility | TX, UT |
| Drug | CLASS II | Semaglutide Injection 5 mg/mL) Multidose Vial, For Subcutaneous Use recalled | ProRx | Sterility | TX, UT |
| Drug | CLASS II | Tirzepatide Injection, 27 mg/ (9 mg/mL) Multidose Vial recalled by ProRx | ProRx | Sterility | TX, UT |
| Drug | CLASS II | Semaglutide Injection, 8mg/ 5 mg/mL) Multidose Vial recalled by ProRx | ProRx | Sterility | TX, UT |
| Drug | CLASS II | Semaglutide Injection, 5mg/ 5 mg/mL) Multidose Vial recalled by ProRx | ProRx | Sterility | TX, UT |