Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5… recall
FDA recall D-0305-2025 · initiated Feb 24, 2025
Imprimis NJOF, LLC recalled Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Soluti… in Feb 2025 — an FDA Class III recall (D-0305-2025) because Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
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: 2822 bottles
Details
- Product
- Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
- Recalling company
- Imprimis NJOF, LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- FL and NY
- Initiated
- Feb 24, 2025
- FDA report date
- Apr 9, 2025
Frequently asked
- Was Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Soluti… recalled?
- Imprimis NJOF, LLC recalled Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Soluti… in Feb 2025 — an FDA Class III recall (D-0305-2025) because Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Soluti… recalled?
- Per the FDA enforcement record, the reason for recall D-0305-2025 was: Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
- Is a recalled Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Soluti… 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 Sterile Ophthalmic Soluti… are affected?
- Distributed: FL and NY. The recall covers these lots — Lot 24OCT041, Exp 04/26/2025. 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-0305-2025.