Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe
Summary
The FDA issued a Class II for Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophth by Fagron Compounding Services. Reason: Incorrect Product Formulation.
Details
Source
Drug Recall
External ID
D-0221-2026
Action Date
2025-12-17
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot#: C274-000047958; Exp. December 19, 2025
Quantity Affected: 2980 syringes
Reason for Recall
Incorrect Product Formulation
Distribution
U.S. Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-20
Company
Wichita, KS
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 54 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fagron Compounding Services has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fagron Compounding Services) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fagron Compounding Services have FDA actions?
Fagron Compounding Services has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0221-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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