D-0116-2026Class II

ProRx LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

ProRx LLC

Product type

Drug

Status

Ongoing

Report date

2025-11-05

Distribution

TX and UT

Firm state

Product quantity

8,310 vials

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

Lack of Assurance of Sterility

Product description

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

Code / lot info

Lot Prorx051425-2, Lot Prorx051425-3 and Lot Prorx051425-4

Other recalls SPEQ maps to Environmental Monitoring

2026-10-21Class IIHouston Rx LLC 2026-10-21Class IIHowmedica Osteonics Corp.2026-10-21Class IIHowmedica Osteonics Corp.2026-10-21Class IIMedtronic Sofamor Danek USA Inc

See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →