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Health & beauty United States Recall (ongoing)

ProRx LLC recalls Semaglutide Injection and 6 more products

Semaglutide Injection (2.5 mg/mL in 1 mL–5 mL multidose vials; NDCs include 84139-225-02, -04, -06, -08, -09) and Tirzepatide Injection 27 mg/3 mL (NDC 84139-209-03), all manufactured by ProRx LLC, Exton, PA, are included in the recall. The products were recalled because of lack of assurance of sterility and were distributed in Texas and Utah.

What's being recalled

Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09

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

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

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

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

Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02

Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03

Recalling firm: ProRx LLC, Exton, PA, United States.

How to identify it

Lot# Prorx04282025-3 Lot, Best Use Date (BUD): Lot PRORX050925-1, BUD November 4, 2025; Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025 Lot Prorx051425-2, Lot Prorx051425-3 and Lot Prorx051425-4 Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4 Lot Prorx051525-5 Lot PRORX052125-4 Lot PRORX08062025-3

The hazard

Lack of Assurance of Sterility

What to do

Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.

The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.

Where it was sold

TX and UT

The official notice

This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.

Read the official notice (opens in a new tab)

A little guidance

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