FDA Drugs recall ·

Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial… recall

Recall number
D-0118-2026
Date
(initiated October 15, 2025)
Company / brand
ProRx LLC
619 Jeffers Cir, Exton, PA, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
2,649 vials
Hazard tags
Sterility
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06

Why was it recalled?

Lack of Assurance of Sterility

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot Prorx051525-5

Distribution

TX and UT

States: Texas Utah

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0118-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.