# FDA recall D-0221-2026

> **Fagron Compounding Services** · Class II · drug recall initiated 2025-11-20.

## 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

## Reason for recall

Incorrect Product Formulation

## Distribution

U.S. Nationwide.

## Key facts

- **Recall number:** D-0221-2026
- **Recalling firm:** Fagron Compounding Services
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-11-20
- **Report date:** 2025-12-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wichita, KS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0221-2026

## Citation

> AI Analytics. FDA recall D-0221-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0221-2026. Source: US FDA. Licensed CC0.

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