Recalls / Class II
Class IID-0221-2026
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
- Affected lot / code info
- Lot#: C274-000047958; Exp. December 19, 2025
Why it was recalled
Incorrect Product Formulation
Recalling firm
- Firm
- Fagron Compounding Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8710 E 34th St N, N/A, Wichita, Kansas 67226-2636
Distribution
- Quantity
- 2980 syringes
- Distribution pattern
- U.S. Nationwide.
Timeline
- Recall initiated
- 2025-11-20
- FDA classified
- 2025-12-08
- Posted by FDA
- 2025-12-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0221-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.