FDA classifies a Class II recall of ProRx compounded semaglutide injections

The U.S. Food and Drug Administration has classified a Class II recall covering multiple semaglutide injection products made by ProRx LLC, a compounding pharmacy in Exton, Pennsylvania.^[1] The recall involves more than 36,000 vials in concentrations ranging from 2.5 mg/mL to 2.5 mg/1mL, packaged as multidose vials meant for subcutaneous injection.^[1] ProRx started the voluntary recall on October 15, 2025, and the FDA classified it as Class II on October 27, 2025.^[1]

The recall was prompted by a lack of assurance of sterility, not by confirmed contamination.^[1] For an injectable drug, that distinction matters: sterility assurance means a manufacturer has verified, through testing and process controls, that a product is free of harmful microorganisms before it reaches a patient. Without that assurance, the FDA says there is a potential risk of local site infections, systemic illness, or other adverse reactions tied to non-sterile injectable products.^[1]

The affected lots were distributed in Texas and Utah and are tied to specific NDC numbers, including 84139-225-02, 84139-225-04, 84139-225-06, 84139-225-08, and 84139-225-09.^[1] The FDA listed the specific recalled lot numbers, which range from batches dated April through May 2025, including PRORX04282025-3, PRORX050925-1, PRORX051425-2 through PRORX051425-6, PRORX051525-1 through PRORX051525-5, and PRORX052125-4.^[1]

A Class II designation is the FDA's middle tier of recall severity. It means the agency believes use of the product may cause temporary or medically reversible health effects, and that the chance of serious injury is remote, though not zero.^[1] The FDA's report does not say any patient has been harmed by these specific vials.^[1]

Why it matters for patients

Semaglutide is the active ingredient in the FDA-approved drugs Ozempic, Wegovy, and Rybelsus, but this recall involves a compounded version made by a pharmacy, not one of those brand-name products.^[1] Compounded semaglutide is often used off-label for weight management or blood sugar control when brand-name supply is tight or when a prescriber orders a customized formulation.^[1] Because compounded drugs are not subject to the same FDA manufacturing approval process as brand-name drugs, sterility and quality problems like this one can surface after the product has already reached pharmacies and patients.

Patients in Texas or Utah who received a ProRx semaglutide injection may want to check whether their vial matches one of the listed lot numbers or NDCs.^[1] The FDA's report notes that pharmacists and health care providers who received the affected products should identify and remove them, notify patients, offer sterile alternatives, and watch for adverse events.^[1] The report does not specify what steps individual patients should take beyond checking with the pharmacy or provider that supplied the product.^[1]

The source material for this recall does not confirm reports of illness linked to these particular vials, and it does not identify how many patients received the affected doses.^[1] It also does not describe the specific manufacturing or testing failure that led to the loss of sterility assurance beyond stating the general concern.^[1]

What happens next

The FDA classified the recall on October 27, 2025, following ProRx's voluntary action that began October 15, 2025.^[1] The source does not list a closure date or describe further FDA enforcement steps beyond the classification itself.^[1] Details on any follow-up inspection findings or additional affected lots are not available in the material reviewed here.