CLASS III Drug recall · Reported 30 Jul 2025 · FDA Enforcement Report
Tropicamide-Proparacaine-Phenylephrine-Ketorolac recalled
Imprimis Njof is recalling Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5%, distributed nationwide in the US. The recall was initiated on 9 Jul 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0536-2025
- FDA event ID
- 97183
- Recalling firm
- Imprimis Njof, Ledgewood, NJ
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 9 Jul 2025
- FDA classified
- 21 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 9 Jul 2025 | Recall initiated by company | |
| 21 Jul 2025 | Classified by FDA | +12 days |
| 30 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub-Potent Drug: Subpotent assay results during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Sub-Potent Drug: Subpotent assay results during stability testing.
Which lots are affected?
Lot: 25MAR032, Exp. 07/16/2025.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97183| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, mL Vials recalled | Imprimis Njof | Potency & Assay | Nationwide |
More recalls from Imprimis Njof
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Moxifloxacin, 1 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS II | Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL recalled | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS II | Tri-Moxi+¿ (Triamcinolone 9mg recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS III | Klarity-C Drops (Cyclosporine) recalled by Imprimis NJOF | Imprimis Njof | Potency & Assay | Nationwide |
| Drug | CLASS II | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, mL Vials recalled | Imprimis Njof | Potency & Assay | Nationwide |