Tropicamide-Proparacaine-Phenylephrine-Ketorolac recall
FDA recall D-0536-2025 · initiated Jul 9, 2025
Imprimis NJOF, LLC recalled Tropicamide-Proparacaine-Phenylephrine-Ketorolac in Jul 2025 — an FDA Class III recall (D-0536-2025) because Sub-Potent Drug: Subpotent assay results during stability testing.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Sub-Potent Drug: Subpotent assay results during stability testing.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,890 vials
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
Frequently asked
- Was Tropicamide-Proparacaine-Phenylephrine-Ketorolac recalled?
- Imprimis NJOF, LLC recalled Tropicamide-Proparacaine-Phenylephrine-Ketorolac in Jul 2025 — an FDA Class III recall (D-0536-2025) because Sub-Potent Drug: Subpotent assay results during stability testing. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Tropicamide-Proparacaine-Phenylephrine-Ketorolac recalled?
- Per the FDA enforcement record, the reason for recall D-0536-2025 was: Sub-Potent Drug: Subpotent assay results during stability testing.
- Is a recalled Tropicamide-Proparacaine-Phenylephrine-Ketorolac dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Tropicamide-Proparacaine-Phenylephrine-Ketorolac are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot: 25MAR032, Exp. 07/16/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0536-2025.