Why it was recalled
Incorrect Product Formulation
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: C274-000047958; Exp. December 19, 2025
Where it was sold
U.S. Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0221-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 20, 2025
- FDA report date
- Dec 17, 2025
- Quantity
- 2980 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron Compounding Services
Original FDA data
Every field from FDA enforcement report D-0221-2026, exactly as published.
Show all FDA fields
- City
- Wichita
- State
- KS
- Status
- Ongoing
- Country
- United States
- Event ID
- 98040
- Address
- 8710 E 34th St N
- Code information
- Lot#: C274-000047958; Exp. December 19, 2025
- Postal code
- 67226-2636
- Report date
- Dec 17, 2025
- Product type
- Drugs
- Recall number
- D-0221-2026
- Classification
- Class II
- Recalling firm
- Fagron Compounding Services
- Product quantity
- 2980 syringes
- Reason for recall
- Incorrect Product Formulation
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- Nov 20, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 8, 2025