Fagron Compounding Services recalls Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syring…

Recall date

November 20, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0221-2026

FDA classification

Class II

Brand / firm

Fagron Compounding Services

Sold / distributed

U.S. Nationwide.

Why it was recalled

Incorrect Product Formulation

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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