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Home › FDA recalls › Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorola
CLASS II · ModerateFDA

Fagron Compounding Services recalls Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solu

📅 Nov 20, 2025 · 📍 Nationwide
Recalling company
Fagron Compounding Services
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
Incorrect Product Formulation
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Nov 20, 2025
Reported
Dec 17, 2025
Distribution
U.S. Nationwide.
Status
Ongoing
Quantity
2980 syringes
Lot / codes
Lot#: C274-000047958; Exp. December 19, 2025
Company location
Wichita, KS
Recall type
Voluntary: Firm initiated
Recall number
D-0221-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0221-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.