Fagron Compounding Services: Drug Recall

Recall #D-0221-2026 · 11/20/2025

Class II: Risk

Recall Details

Recall Number: D-0221-2026
Classification: Class II
Product Type: Drug
Recalling Firm: Fagron Compounding Services
Status: Ongoing
Date Initiated: 11/20/2025
Location: Wichita, KS, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2980 syringes

Reason for Recall

Incorrect Product Formulation

Product Description

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01

Distribution Pattern

U.S. Nationwide.

Other Recalls by Fagron Compounding Services

Class II: Risk 08/29/2025

Lack of Assurance of Sterility
Class II: Risk 01/31/2025

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.