ImprimisRx NJ recall: Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution
ImprimisRx NJ LLC is recalling Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution because of the wrong strength – 772 bottles. The U.S. Food and Drug Administration published the recall on September 16, 2026; it began on August 24, 2026. Distributed nationwide.
Lower risk Class III means using the product is not likely to cause health problems; it breaks a labeling or manufacturing rule.
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| Product | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution |
| Brand | ImprimisRx NJ |
| Company | ImprimisRx NJ LLC |
| Type | Drugs |
| Classification | Class III |
| Recall date | August 24, 2026 |
| Published by FDA | September 16, 2026 |
| Quantity | 772 bottles |
| Recall ID | 99756 |
Recalled products
- 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
- FDA recall number
- D-0835-2026
- Codes, lots and dates
- Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
- Quantity
- 772 bottles
- Classification
- Class III
Identifiers and details
- FDA event ID
- 99756
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Ledgewood, NJ, United States
Why it was recalled
The problem: the wrong strength.
The reason the FDA lists: “Subpotent Drug”
Where it was sold
Nationwide. Distribution as the FDA records it: “USA Nationwide”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99756, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is ImprimisRx NJ Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution recalled?
Yes. ImprimisRx NJ LLC recalled it on August 24, 2026; FDA published it September 16, 2026 (Class III). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of the wrong strength. The reason given: Subpotent Drug
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.