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Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only...

FDA Recall #D-0117-2026 — Class II — October 15, 2025

Recall #D-0117-2026 Date: October 15, 2025 Classification: Class II Status: Ongoing

Product Description

Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

ProRx LLC — Exton, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

11,119 vials

Distribution

TX and UT

Code Information

Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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