Fagron Compounding Services recalled 2,980 syringes of a topical ophthalmic solution on November 20, 2025. The recall stems from an incorrect product formulation that could pose health risks. Consumers should stop using the product immediately and contact their healthcare provider for guidance.
Incorrect Product Formulation
Consumers and healthcare providers should stop using this product immediately. Contact Fagron Compounding Services or your healthcare provider for guidance. Notification method: Letter
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The affected product is Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, packaged in 0.5mL single-use syringes. It is distributed by Fagron Sterile Services, located at 8710 E 34th St N, Wichita, KS 67226. The National Drug Code (NDC) is 71266-8240-01.
The recall is classified as Class II due to an incorrect product formulation. This formulation error poses a high risk to consumers, potentially leading to adverse health effects if administered.
There have been no reported injuries or incidents related to the use of this product thus far. Consumers are urged to report any adverse effects to their healthcare provider.
Stop using the product immediately. Contact Fagron Compounding Services or your healthcare provider for further guidance. Notifications are being sent out via letter.
For more information, contact Fagron Compounding Services directly. Visit their website or call their customer service for assistance.
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