Medications & Supplements/Prescription Drugs

Tropicamide/Cyclopentolate/Phenylephrine/Ketorolac Eye Drops Recalled

Agency Publication Date: December 8, 2025

Summary

Fagron Compounding Services is recalling 2,980 syringes of a sterile eye drop solution containing Tropicamide, Cyclopentolate, Phenylephrine, and Ketorolac. The recall was initiated because the product was manufactured with an incorrect formulation, meaning the ingredients are not at the correct concentrations. These single-use syringes were distributed nationwide to healthcare facilities and providers.

Risk

Using a medication with an incorrect formulation can lead to ineffective treatment or unexpected side effects during ophthalmic procedures. Because these are sterile injectable syringes used in clinical settings, an incorrect chemical balance poses a risk to patient safety.

What You Should Do

Identify if you have the affected product by checking the label for Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution in 0.5mL single-use syringes.
Check the packaging for Lot number C274-000047958 with an expiration date of December 19, 2025.
Confirm the NDC (National Drug Code) on the syringe or carton matches 71266-8240-01.
Stop using the recalled product immediately.
Contact Fagron Sterile Services or your distributor to arrange for the return of any remaining syringes.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution (0.5mL)

Variants: Single-Use Syringe

Lot Numbers:

C274-000047958 (Exp. December 19, 2025)

NDC:

71266-8240-01

Recall #: D-0221-2026. For Topical Ophthalmic Use Only. Not for IV Use.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98040

Status: Active

Manufacturer: Fagron Compounding Services

Sold By: Hospitals; Surgical centers; Healthcare providers; Wholesalers

Manufactured In: United States

Units Affected: 2980 syringes

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected product by checking the label for Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution in 0.5mL single-use syringes.

Check the packaging for Lot number C274-000047958 with an expiration date of December 19, 2025.

Confirm the NDC (National Drug Code) on the syringe or carton matches 71266-8240-01.

Stop using the recalled product immediately.

Contact Fagron Sterile Services or your distributor to arrange for the return of any remaining syringes.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.