Class II Recall for ProRx Semaglutide Injections Due to Lack of Sterility Assurance
The US Food and Drug Administration (FDA) has issued a Class II recall for multiple semaglutide injection formulations manufactured and distributed by ProRx LLC, located in Exton, Pennsylvania. The recall includes various concentrations—ranging from 2.5 mg/mL to 2.5 mg/1mL—packaged in multidose vials for subcutaneous use, totaling more than 36 000 vials. The recall affects several lots across NDCs including 84139-225-02, 84139-225-04, 84139-225-06, 84139-225-08, and 84139-225-09. The issue was prompted by a lack of assurance of sterility, a critical concern for injectable products. The voluntary recall was initiated on October 15, 2025, and the affected products were distributed across Texas and Utah.
This recall was classified by the FDA as Class II on October 27, 2025, indicating that use of these products may cause temporary or medically reversible adverse health effects, though the risk of serious injury is remote. While no contamination has been confirmed, the absence of sterility assurance presents a potential risk for local site infections, systemic illness, or other adverse reactions associated with non-sterile injectable therapies.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for chronic weight management and glycemic control in type 2 diabetes mellitus, and is often used off-label through compounding pharmacies like ProRx. Pharmacists and health care providers in TX and UT who may have received the recalled products should immediately identify and remove the following affected lots:
• PRORX04282025-3
• PRORX050925-1
• PRORX051425-2 to PRORX051425-6
• PRORX051525-1 to PRORX051525-5
• PRORX052125-4
Providers should notify patients, offer sterile alternatives, and monitor for potential adverse events. Given the growing demand for semaglutide and increasing compounding activity, pharmacists must ensure quality, sterility, and FDA-compliant sourcing for all injectable medications.
Reference
FDA. Enforcement Report. October 29, 2025. Accessed October 30, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm
