RECALL DATABASE

Ophthalmic Solution Recall: ImprimisRx Povidone Iodine 1.25%

Announced 2026-09-16 · FDA

FDA is recalling Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL dropper bottles labeled For Office Use Only. The product is recalled due to subpotent drug potency. A total of 772 bottles distributed nationwide in the USA are affected; the recalled lots are Lot 26JAN035 (BUD 09/07/2026) and Lot 26FEB015 (BUD 09/24/2026).

BrandImprimisRx NJ LLC
ProductPovidone 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
ReasonSubpotent Drug
Severitylow
Units affected772
DistributionUSA Nationwide
AgencyFDA

WHAT YOU SHOULD DO

  1. Check if you have Lot 26JAN035 or 26FEB015 and discontinue use.
  2. Contact your ophthalmologist or supplier for instructions and possible return or replacement.
  3. If you have used the product, monitor for eye symptoms and seek medical advice if needed.

How to identify the recalled item

Lot / date codesLot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
Lot / date codesLot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026

These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.

This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.