FDA Recall D-0221-2026

Fagron Compounding Services · Wichita, KS

Class II Ongoing 175 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot#: C274-000047958; Exp. December 19, 2025

Quantity: 2980 syringes

Reason for recall

Incorrect Product Formulation

Recall record

Recall number: D-0221-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide.
Recall initiated: 2025-11-20
Classified by FDA Center: 2025-12-08
FDA published: 2025-12-17
Recalling firm: Fagron Compounding Services
Firm location: Wichita, KS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls