Two firm-initiated Class II recalls cover 8,400 vials of one multidose presentation and 8,310 of another, distributed in Texas and Utah.
Silver Spring, Maryland, 5 November 2025 — The Food and Drug Administration enforcement file records two ongoing Class II recalls initiated by ProRx LLC of Exton, Pennsylvania, on 15 October 2025 and classified on 27 October 2025.
The two records cover multidose vials of compounded semaglutide injection in two presentations, 8,400 vials under one recall number and 8,310 under the other. Both are recorded as voluntary and firm-initiated, with customers notified by letter, and both give the reason as lack of assurance of sterility. The distribution pattern recorded on each is Texas and Utah.
Source documents
-
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
- Identifier
- Recall number D-0115-2026
- As the record states
- Lack of Assurance of Sterility
- Recalling firm
- ProRx LLC
- Firm location
- Exton, PA, United States
- Classification
- Class II
- Status on the record
- Ongoing
- Quantity
- 8,400 vials
- Distribution
- TX and UT
- Initiated
- 2025-10-15
- Classified
- 2025-10-27
-
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
- Identifier
- Recall number D-0116-2026
- As the record states
- Lack of Assurance of Sterility
- Recalling firm
- ProRx LLC
- Firm location
- Exton, PA, United States
- Classification
- Class II
- Status on the record
- Ongoing
- Quantity
- 8,310 vials
- Distribution
- TX and UT
- Initiated
- 2025-10-15
- Classified
- 2025-10-27