FDA recall, , Low risk
ImprimisRx NJ Povidone Iodine and Proparacaine Ophthalmic Solution
The ophthalmic solution is subpotent.
Summary by Recall Canary from the FDA notice
What happened
ImprimisRx NJ LLC of Ledgewood, New Jersey, is recalling Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, because the product is subpotent. The recall began on August 24, 2026, and was added to the FDA's Enforcement Report on September 8, 2026.
The product was distributed nationwide in the USA. The recalled item is identified as Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. The recall involves 772 bottles.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Povidone Iodine 1.25% Proparacaine HCl 0.5% Ophthalmic Solution
- NDC
- 71384-732-10
- Lot code
- 26JAN035
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- ImprimisRx NJ LLCLedgewood, New Jersey
- Hazard
- Wrong drug strength
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99756
- Recall number
- D-0835-2026
- Quantity recalled
- 772 bottles
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
