Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution recall
FDA recall D-0835-2026 · initiated Aug 24, 2026
ImprimisRx NJ LLC recalled Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution in Aug 2026 — an FDA Class III recall (D-0835-2026) because Subpotent Drug.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Subpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 772 bottles
Details
- 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
- Recalling company
- ImprimisRx NJ LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Aug 24, 2026
- FDA report date
- Sep 16, 2026
Frequently asked
- Was Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution recalled?
- ImprimisRx NJ LLC recalled Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution in Aug 2026 — an FDA Class III recall (D-0835-2026) because Subpotent Drug. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0835-2026 was: Subpotent Drug
- Is a recalled Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0835-2026.