CLASS III ONGOING Drug recall · Reported 9 Apr 2025 · FDA Enforcement Report
Tropicamide - Proparacaine - Phenylephrine recalled by Imprimis NJOF
Imprimis NJOF is recalling Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1%, distributed in Florida, New York. The recall was initiated on 24 Feb 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-0305-2025
- FDA event ID
- 96329
- Recalling firm
- Imprimis NJOF, Ledgewood, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 24 Feb 2025
- FDA classified
- 28 Mar 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 24 Feb 2025 | Recall initiated by company | |
| 28 Mar 2025 | Classified by FDA | +32 days |
| 9 Apr 2025 | Published in enforcement report | +12 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: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
FL and NY
Questions about this recall
Is Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% recalled?
Yes. Imprimis NJOF recalled Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% on 24 Feb 2025. The recall is Class III and its status is Ongoing. Recall number D-0305-2025.
Why was it 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.
Which lots are affected?
Lot 24OCT041, Exp 04/26/2025
Where was it sold?
FL and NY
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Foreign Material | Nationwide |
| Drug | CLASS II | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, mL Vials recalled | Imprimis NJOF | Foreign Material | Nationwide |