Tirzepatide Injection Recalled for Lack of Sterility Assurance
ProRx LLC is recalling 2,761 vials of Tirzepatide Injection due to lack of assurance of sterility. The affected lot was distributed to Texas and Utah.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II injectable drug recall for lack of sterility assurance—a serious potential hazard. However, no illnesses or injuries have been reported, making the harm theoretical. Per the rubric, lack of reported illness with theoretical risk of harm scores at 3 (High).
Plain-English summary
ProRx LLC is recalling 2,761 vials of Tirzepatide Injection (27 mg/3 mL, NDC 84139-209-03, Lot PRORX08062025-3) for lack of assurance of sterility. The product is a multidose vial for subcutaneous injection. The affected lot was distributed to Texas and Utah.
Tirzepatide is a prescription injectable medication. A lack of assurance of sterility means there is no confirmed guarantee that the product is free from microbial contamination. For injectable drugs, sterility is critical to patient safety, as contamination could lead to serious infections.
Patients who have received injections from the recalled lot should consult their healthcare provider. Healthcare providers and patients should stop using the recalled product and contact ProRx LLC or the FDA for guidance on obtaining replacement product or alternative treatment options.
As of the date of this recall, no illnesses or adverse events have been reported in connection with this product lot.
The recalled product
- Product
- 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
- Manufacturer
- ProRx LLC
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot PRORX08062025-3
Distribution
Distributed in 2 states:
- TX
- UT
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