Compounded semaglutide vials recalled for lack of sterility assurance
ProRx is recalling 2,809 vials of Semaglutide Injection 12.5 mg/5 mL from one lot for lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in an injectable creates an infection risk, and no injuries are reported.
Plain-English summary
Semaglutide Injection, 12.5 mg/5 mL (2.5 mg/mL), in 5 mL multidose vials for subcutaneous use, compounded by ProRx of Exton, Pennsylvania, is being recalled for lack of assurance of sterility.
The recall covers 2,809 vials from lot Prorx04282025-3, carrying NDC 84139-225-09, distributed in Texas and Utah. The FDA has classified the recall as Class II.
Sterility matters for an injectable because the product is administered directly into the body. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Patients and providers holding the affected lot should stop using it and contact the firm or their prescriber.
The recalled product
- Product
- Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
- Manufacturer
- ProRx LLC
- Category
- Drug — Injectable
- Affected units
- 2,809
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# Prorx04282025-3
Distribution
Part of a larger recall action
This product is one of 7 recalled by ProRx LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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