Class IIICompleted

Tropicamide-Proparacaine-Phenylephrine-Ketorolac recall

FDA recall D-0536-2025 · initiated Jul 9, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Sub-Potent Drug: Subpotent assay results during stability testing.

Details

Product: Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
Recalling company: Imprimis NJOF, LLC
Classification: Class III
Status: Completed
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Jul 9, 2025
FDA report date: Jul 30, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0536-2025 ↗

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