FDAHealthNovember 20, 2025
Fagron Compounding Services — 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
⚠️ Incorrect Product Formulation
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 20, 2025
U.S. Nationwide.
What's affected?
- 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
- C274-000047958
Additional details
Lot#: C274-000047958; Exp. December 19, 2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2980 syringes.
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