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, 871

Recall Summary Fagron Sterile Services is recalling eye drops in 0.5mL single-use syringes that contain an incorrect formulation of the medication mixture. The product was distributed nationwide across all U.S. states. This is a serious (Class I) recall because the product was not made as intended.

Recalling firm

Fagron Compounding Services

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

Reason

Incorrect Product Formulation

Classification

Class I

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2025-11-20

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S. Nationwide.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/319b05fa-b111-4a03-b236-a5f9f760fc4b