Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0...
FDA Recall #D-0221-2026 — Class II — November 20, 2025
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
Reason for Recall
Incorrect Product Formulation
Recalling Firm
Fagron Compounding Services — Wichita, KS
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2980 syringes
Distribution
U.S. Nationwide.
Code Information
Lot#: C274-000047958; Exp. December 19, 2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated