Compounded ophthalmic syringes recalled over an incorrect product formulation
Fagron Compounding Services is recalling 2,980 syringes of a compounded topical ophthalmic solution over an incorrect product formulation.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an incorrect formulation without describing the difference, a consequence or any reported harm.
Plain-English summary
Tropicamide 1% / Cyclopentolate 1% / Phenylephrine 2.5% / Ketorolac 0.5% Topical Ophthalmic Solution, in 0.5mL single-use syringes for topical ophthalmic use only and not for IV use, from Fagron Sterile Services of Wichita, Kansas, under NDC 71266-8240, is being recalled.
The reason given in the enforcement record is incorrect product formulation.
The recall covers 2,980 syringes from lot C274-000047958, expiry December 19, 2025. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record does not describe how the formulation differed or state a consequence, and reports no injuries. Facilities should quarantine the affected lot and follow Fagron's instructions.
The recalled product
- 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
- Manufacturer
- Fagron Compounding Services
- Category
- Drug — Compounded ophthalmic
- Affected units
- 2,980
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot#: C274-000047958
- Exp. December 19
- 2025
Distribution
Distributed nationwide across the United States.
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