November 2025 FDA Recall Drug by Fagron Compounding Services
D-0221-2026 - Incorrect Product Formulation

This Class II drug recall was voluntarily initiated by Fagron Compounding Services on November 20, 2025 for the product Drug. The FDA reported the reason for recall as incorrect product formulation. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0221-2026

Reason for Recall
Incorrect Product Formulation
Initiated
11-20-2025
Reported
12-17-2025
Quantity
2980 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98040
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fagron Compounding Services
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide.
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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