FDA-Drug2026-09-16Class IIIMISBRANDING
ImprimisRx ophthalmic solution recalled for subpotent drug formulation
What this means
ImprimisRx NJ LLC is recalling specific lots of Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution used in medical offices because the medication contains lower-than-intended active ingredients. The affected lots may not work as intended for their intended use.
- If your medical office received this product, stop using the affected lots (26JAN035 and 26FEB015) immediately
- Contact ImprimisRx NJ LLC or your supplier about replacement product
- Consult your eye care provider if you received this medication and have concerns
The agency's original wording
Hazard
Subpotent Drug
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
772 bottles
Manufactured in
1705 Us Highway 46 Ste 4, Ledgewood, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0835-2026Want us to check the next one for you?
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