Fagron Compounding Services: Drug Recall

Recall #D-0225-2025 · 01/31/2025

Class II: Risk

Recall Details

Recall Number: D-0225-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Fagron Compounding Services
Status: Completed
Date Initiated: 01/31/2025
Location: Wichita, KS, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1330 bags

Reason for Recall

Lack of Assurance of Sterility

Product Description

fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

Distribution Pattern

Distributed in PA

Other Recalls by Fagron Compounding Services

Class II: Risk 11/20/2025

Incorrect Product Formulation
Class II: Risk 08/29/2025

Lack of Assurance of Sterility
Class II: Risk 08/15/2024

Lack of Assurance of Sterility
Class III: Low Risk 11/10/2023

Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

View all recalls by Fagron Compounding Services →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.