Semaglutide 10 mg vials recalled for lack of sterility assurance

Plain-English summary

Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), in 4 mL multidose vials for subcutaneous use, compounded by ProRx of Exton, Pennsylvania, is being recalled for lack of assurance of sterility.

The recall covers 8,400 vials carrying NDC 84139-225-04, including lot PRORX050925-1 (best use date 4 November 2025) and lot ProRx051425-5 (best use date 10 November 2025), 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 an affected lot should stop using it and contact the firm or their prescriber.

The recalled product

Product

Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04

Manufacturer

ProRx LLC

Category

Drug — Injectable

Hazard

• sterility-assurance
• infection-risk
• compounded
• injectable

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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