The Recall Desk
HighFDA (Drugs)·D-0116-2026·Announced 2025-11-05

Semaglutide Injection Vials Recalled Due to Sterility Concerns

ProRx is recalling 8,310 vials of semaglutide injection due to lack of sterility assurance. The affected lots were distributed in Texas and Utah.

What this means for you

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: This is an FDA Class II recall of an injectable drug with a potential sterility issue. No illnesses or injuries have been reported. Per the severity rubric, unconfirmed contamination risks with no reported harm score at most 3 (High).

Plain-English summary

ProRx LLC is recalling semaglutide injection 6mg/2.4mL multidose vials due to lack of assurance of sterility. The vials are intended for subcutaneous use and are prescription-only. A total of 8,310 vials are being recalled.

The affected lots are Prorx051425-2, Prorx051425-3, and Prorx051425-4. These lots were distributed in Texas and Utah. The product has NDC 84139-225-08.

Consumers who have been prescribed this medication from the recalled lots should contact their healthcare provider or pharmacist immediately. Healthcare providers and patients should not use the recalled vials. The lack of sterility assurance means the vials may not meet proper safety standards for injection.

The recalled product

Product
Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08
Manufacturer
ProRx LLC
Category
Drug — Injectable / Prescription
Hazard
  • lack-of-sterility
  • infection-risk

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 (2)

  • Lot Prorx051425-2
  • Lot Prorx051425-3 and Lot Prorx051425-4

Distribution

Distributed in 2 states:

  • TX
  • UT

Related recalls

Same category