FDA Drug recall D-0305-2025
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis…
- FDA Drug
- Class III
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class III recall of Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis… by Imprimis Njof, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0305-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-02-24 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Imprimis Njof |
| Distribution | FL, NY |
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.
Reason
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.
Identifiers
| code_info | Lot 24OCT041, Exp 04/26/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Imprimis Njof
- Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-51…
FDA Drug · Class II · 2026-01-14 · Imprimis Njof - Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 W…
FDA Drug · Class II · 2026-01-14 · Imprimis Njof - Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West…
FDA Drug · Class II · 2026-01-14 · Imprimis Njof - Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bott…
FDA Drug · Class III · 2025-11-26 · Imprimis Njof - 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 · 2025-07-30 · Imprimis Njof
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0305-2025%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.