Warning
Fagron Compounding Services Recalls Tropicamide 1%/Cyclopentolate 1%/Phenylephrine
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0221-2026Drug / Pharmaceutical
Fagron Compounding Services Recalls Tropicamide 1%/Cyclopentolate 1%/Phenylephrine
Fagron Compounding Services · Class II — Moderate Risk
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Fagron Compounding Services initiated the recall on November 20, 2025 affecting 2980 syringes. Incorrect Product Formulation. The product was distributed in U.S. Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Fagron Compounding Services for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.