FDA Recalls Semaglutide Injection Vials for Lack of Sterility Assurance
ProRx LLC is recalling 2,809 vials of semaglutide injection (NDC 84139-225-09) from lot Prorx04282025-3 due to lack of assurance of sterility. Affected vials were distributed to 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 involving an injectable medication with a sterility assurance defect. While no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where contamination could lead to serious infection. Per the rubric, an injectable lacking sterility assurance with no reported illness falls within High (score 3).
Plain-English summary
ProRx LLC is recalling 2,809 vials of semaglutide injection (2.5 mg/mL, 5mL multidose vials, NDC 84139-225-09) from lot Prorx04282025-3. The recall is due to lack of assurance of sterility.
The affected vials were distributed to Texas and Utah. Because the product lacks assured sterility, contaminated vials could pose a risk of infection if used.
Patients using vials from lot Prorx04282025-3 should discontinue use immediately and contact their healthcare provider for guidance on obtaining replacement medication. Do not use any vials from the affected lot without consulting your healthcare provider first.
The recalled product
- Product
- Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
- Manufacturer
- ProRx LLC
- Category
- Drug — Injectable Medication
- Hazard
- sterility-failure
- 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 (1)
- Lot# Prorx04282025-3
Distribution
Distributed in 2 states:
- TX
- UT
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27