Class IIIDrug
Povidone Iodine 1.25% / Proparacaine HCl 0.5%… recall
Summary
ImprimisRx NJ LLC is recalling Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution (drug). According to the FDA report, the reason is: Subpotent Drug. The FDA rated this a Class III: the product is unlikely to cause health problems but violates fda rules (e.g. labeling). Recall status: Ongoing.
Details from the FDA report
- Product
- 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
- Lot / code info
- Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
- Quantity
- 772 bottles
- Distribution
- USA Nationwide
- Recalling company
- ImprimisRx NJ LLC, Ledgewood, NJ United States
- Recall started
- August 24, 2026
- FDA report date
- September 16, 2026
- Classification
- Class III: The product is unlikely to cause health problems but violates FDA rules (e.g. labeling).
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0835-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (ImprimisRx NJ LLC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.