Semaglutide Injection — Class II drug recall D-0116-2026
Ongoing recall by ProRx LLC, reported 2025-11-05, distributed in TX, UT. Lack of Assurance of Sterility
| Recall number | D-0116-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ProRx LLC, Exton, PA, United States |
| Recall initiated | 2025-10-15 |
| Classified | 2025-10-27 |
| Reported by FDA | 2025-11-05 |
| Distributed | TX, UT |
| Quantity | 8,310 vials |
| Reason classes | sterility |
| NDC | 84139-0225-08 |
| Lot numbers | PRORX051425-2, PRORX051425-3, PRORX051425-4 |
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
Reason for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0116-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.