FDA Drug recall D-0221-2026
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophth…
- FDA Drug
- Class II
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class II recall of Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophth… by Fagron Compounding Services, citing incorrect Product Formulation.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0221-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-20 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fagron Compounding Services |
| Distribution | US |
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
Incorrect Product Formulation
Identifiers
| code_info | Lot#: C274-000047958; Exp. December 19, 2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0221-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.