Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solu… recall

Why it was recalled

Incorrect Product Formulation

Details

Product

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

Recalling company

Fagron Compounding Services

Classification

Class II

Status

Ongoing

Type

Voluntary: Firm initiated

Distribution

U.S. Nationwide.

Initiated

Nov 20, 2025

FDA report date

Dec 17, 2025