FDA classifies Class II recall of ProRx compounded semaglutide injections

The US Food and Drug Administration classified a recall of compounded semaglutide injections made by ProRx LLC as Class II on October 27, 2025, after the Exton, Pennsylvania, company pulled more than 36,000 multidose vials because of a lack of sterility assurance ^[1].

ProRx initiated the voluntary recall on October 15, 2025. The affected products were distributed in Texas and Utah, according to the recall report ^[1]. The vials are for subcutaneous use and cover multiple semaglutide concentrations, packaged in multidose vials under National Drug Codes 84139-225-02, 84139-225-04, 84139-225-06, 84139-225-08 and 84139-225-09 ^[1].

Which lots were recalled

The report lists these affected lots ^[1]:

• PRORX04282025-3
• PRORX050925-1
• PRORX051425-2 through PRORX051425-6
• PRORX051525-1 through PRORX051525-5
• PRORX052125-4

The company did not confirm that any of the vials were contaminated. The recall was issued because the company could not assure that the manufacturing process kept the product sterile, which is a requirement for anything injected into the body ^[1].

What Class II means

The FDA assigns Class II to recalls where using the product may cause temporary or medically reversible health effects, with the risk of serious injury described as remote ^[1]. The report notes that a lack of sterility assurance in an injectable creates a potential risk of infection at the injection site, systemic illness, or other adverse reactions linked to non-sterile injectable drugs ^[1].

Semaglutide is a GLP-1 receptor agonist approved for chronic weight management and for blood sugar control in type 2 diabetes. Compounded versions, like the ProRx product, are not FDA-approved drugs ^[1].

Why it matters for patients

Compounded semaglutide has been a common alternative for people who could not get or afford brand-name products, and it is sold in multidose vials that patients typically draw from over several weeks. A sterility problem in that kind of vial matters because the same container is entered repeatedly.

The recall notice directs pharmacists and prescribers in Texas and Utah to identify and remove the listed lots, notify patients who received them, offer sterile alternatives, and watch for possible adverse events ^[1]. The notice does not describe a specific symptom list for patients to watch for beyond the general risks of a non-sterile injection, and it does not say how many patients received the recalled vials.

It has not been reported whether any injuries or infections have been tied to these lots. It has also not been disclosed whether the FDA inspected the ProRx facility, what the inspection found, or whether the recall could expand beyond the lots and two states named so far. The lot number printed on a vial can be compared with the list above ^[1].

What happens next

The FDA's enforcement report is dated October 29, 2025, and the agency's recall classification came two days earlier ^[1]. No further deadlines, follow-up inspections, or expanded recalls have been announced. ProRx is described in the report as the manufacturer and distributor of the recalled product; the company's response beyond initiating the recall has not been reported ^[1].