FDA recall D-0221-2026

Fagron Compounding Services · Class II · drug

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

Reason for recall

Incorrect Product Formulation

Distribution

U.S. Nationwide.

Key facts

Status: Ongoing
Initiation date: 2025-11-20
Report date: 2025-12-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wichita, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0221-2026