CLASS III ONGOING Drug recall · Reported 16 Sep 2026 · FDA Enforcement Report
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled
ImprimisRx NJ is recalling Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution per dropper, For Office, distributed nationwide in the US. The recall was initiated on 24 Aug 2026 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-0835-2026
- FDA event ID
- 99756
- Recalling firm
- ImprimisRx NJ, Ledgewood, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 24 Aug 2026
- FDA classified
- 8 Sep 2026
- Reported
- 16 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Eye Drops
Timeline
| 24 Aug 2026 | Recall initiated by company | |
| 8 Sep 2026 | Classified by FDA | +15 days |
| 16 Sep 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
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
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
Where was it sold?
USA Nationwide
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 22 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 ImprimisRx NJ
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|---|---|---|---|---|---|
| Drug | CLASS II | Timolol-Latanoprost (0.5/0.005%) ophthalmic drops recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | Timolol- Dorzolamide- Latanoprost recalled by ImprimisRx NJ | ImprimisRx NJ | Potency & Assay | Nationwide |