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Semaglutide Sterility Recall

Semaglutide Injection has been recalled due to potential sterility concerns during manufacturing. This recall primarily affects healthcare facilities, hospitals, and pharmacies. Individual consumers are unlikely to have this product at home. Check the official FDA notice for specific lot numbers and return or disposal instructions.

By RecallRadar Editorial Team

Sourced from FDA. Last verified March 4, 2026.

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Key facts

Date announced
October 15, 2025
Source agency
FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Semaglutide Injection has been recalled due to potential sterility concerns during manufacturing. This recall primarily affects healthcare facilities, hospitals, and pharmacies. Individual consumers are unlikely to have this product at home. Check the official FDA notice for specific lot numbers and return or disposal instructions.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

Lack of Assurance of Sterility

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Prorx llc
Category
drug
Source agency
FDA
Announced
October 15, 2025
Country
US
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

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

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1## 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
  2. 2NDC: 84139-225-09 Agency: FDA | Category: drug Reason: Lack of Assurance of Sterility What to do:
  3. 3Stop using the product if your lot/model matches.
  4. 4Check the FDA notice for specifics.
Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
October 15, 2025
Last reviewed by RecallRadar
March 4, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4.

What is the remedy for this recall?

## 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 Agency: FDA | Category: drug Reason: Lack of Assurance of Sterility What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: prorx llc recall hub and Food & Drug recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

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