FDA Drugs recall ·
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical… recall
- Recall number
- D-0221-2026
- Date
- (initiated November 20, 2025)
- Company / brand
- Fagron Compounding Services
8710 E 34th St N, Wichita, KS, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2980 syringes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Incorrect Product Formulation
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: C274-000047958; Exp. December 19, 2025
Distribution
U.S. Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0221-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.