FDA Drug recall D-0536-2025
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Impr…
- FDA Drug
- Class III
- completed
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class III recall of Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Impr… by Imprimis Njof, citing sub-Potent Drug: Subpotent assay results during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0536-2025 |
| Classification | Class III |
| Status | completed |
| Initiated | 2025-07-09 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Imprimis Njof |
| Distribution | US |
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.
Reason
Sub-Potent Drug: Subpotent assay results during stability testing.
Identifiers
| code_info | Lot: 25MAR032, Exp. 07/16/2025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
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FDA Drug · Class III · 2025-11-26 · Imprimis Njof - Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood…
FDA Drug · Class II · 2025-07-30 · Imprimis Njof
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0536-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.