Why it was recalled
Subpotent Drug
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0835-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Aug 24, 2026
- FDA report date
- Sep 16, 2026
- Quantity
- 772 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ImprimisRx NJ LLC
Original FDA data
Every field from FDA enforcement report D-0835-2026, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99756
- Address
- 1705 Us Highway 46 Ste 4
- Code information
- Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
- Postal code
- 07852-9720
- Report date
- Sep 16, 2026
- Product type
- Drugs
- Recall number
- D-0835-2026
- Classification
- Class III
- Recalling firm
- ImprimisRx NJ LLC
- Product quantity
- 772 bottles
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Aug 24, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 8, 2026