Compounded Semaglutide Injection Vials Recalled for Sterility Concerns
ProRx LLC is recalling approximately 8,396 vials of compounded semaglutide due to lack of assurance of sterility. The medication was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of injectable compounded medication with lack of sterility assurance represents a risk-of-harm product where injury has not yet been reported. Potential for serious infection from contaminated injectables warrants preventative action.
Plain-English summary
ProRx LLC is recalling approximately 8,396 vials of compounded semaglutide 5mg/2mL (2.5mg/mL) due to lack of assurance of sterility. The recall affects vials manufactured at ProRx facilities in Exton, Pennsylvania.
The affected medication was distributed nationwide in the United States. Affected lots include ProRx052424 (BUD 11/23/2024), ProRx060724 (BUD 12/06/2024), ProRx061124 (BUD 12/10/2024), and ProRx061924 (BUD 12/18/2024).
Consumers and healthcare providers who have received this compounded semaglutide should not use the affected vials. Patients should consult with their prescribing healthcare provider regarding their medication and explore alternative options. Semaglutide is used for diabetes and weight management; any changes to therapy should be discussed with a healthcare provider.
The recalled product
- Product
- SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
- Manufacturer
- ProRx LLC
- Category
- Drug — Compounded Injection
- Hazard
- Affected units
- 8,396
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 (5)
- Lot #: ProRx052424
- BUD 11/23/2024 ProRx060724
- BUD 12/06/2024 ProRx061124
- BUD 12/10/2024 ProRx061924
- BUD 12/18/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by ProRx LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · ProRx LLC
See all →- HighSemaglutide 8 mg vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- HighCompounded semaglutide vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- HighCompounded tirzepatide vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- HighSemaglutide 5 mg vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- HighSemaglutide 6 mg vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighCompounded semaglutide vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- HighSemaglutide 6 mg vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- HighSemaglutide 5 mg vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- HighSemaglutide 2.5 mg vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- HighSemaglutide 8 mg vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- HighSemaglutide 10 mg vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05