FDAClass IIDecember 17, 2025

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine recall

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use…

Why was Tropicamide 1%/Cyclopentolate 1%/Phenylephrine recalled?

Incorrect Product Formulation

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use…
Recalling firm
Fagron Compounding Services
Quantity
2980 syringes
Distribution
U.S. Nationwide.
Recall date
December 17, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls