Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solu… recall
FDA recall D-0221-2026 · initiated Nov 20, 2025
Fagron Compounding Services recalled Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophth… in Nov 2025 — an FDA Class II recall (D-0221-2026) because Incorrect Product Formulation.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Incorrect Product Formulation
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2980 syringes
Details
- 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
- Recalling company
- Fagron Compounding Services
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide.
- Initiated
- Nov 20, 2025
- FDA report date
- Dec 17, 2025
Frequently asked
- Was Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophth… recalled?
- Fagron Compounding Services recalled Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophth… in Nov 2025 — an FDA Class II recall (D-0221-2026) because Incorrect Product Formulation. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophth… recalled?
- Per the FDA enforcement record, the reason for recall D-0221-2026 was: Incorrect Product Formulation
- Is a recalled Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophth… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophth… are affected?
- Distributed: U.S. Nationwide.. The recall covers these lots — Lot#: C274-000047958; Exp. December 19, 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0221-2026.