Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution recall (ImprimisRx NJ LLC)
DrugClass IIIOngoing
Summary: ImprimisRx NJ LLC is recalling 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. Reason: Subpotent Drug.
What is being recalled
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
Why
Subpotent Drug
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0835-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | August 24, 2026 |
| Reported | September 16, 2026 |
| Company | ImprimisRx NJ LLC |
| Company location | Ledgewood, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 772 bottles |
More recalls from ImprimisRx NJ LLC · all drug recalls · recalls from August 2026