FDAClass IIIJuly 30, 2025

Tropicamide-Proparacaine-Phenylephrine-Ketorolac recall: Subpotent

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF…

Why was Tropicamide-Proparacaine-Phenylephrine-Ketorolac recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 25MAR032, Exp. 07/16/2025.

Product
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF…
Recalling firm
Imprimis NJOF, LLC
Quantity
2,890 vials
Distribution
Nationwide in the USA
Recall date
July 30, 2025
Classification
Class III
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls