ImprimisRx Recalls Subpotent Povidone Iodine and Proparacaine Ophthalmic Solution

Plain-English summary

ImprimisRx NJ LLC is voluntarily recalling 772 bottles of Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle. The product is designated for office use only and is identified by NDC 71384-732-10. The recall was initiated on August 24, 2026.

The reason for the recall is that the drug is subpotent, meaning it does not contain the full amount of the active ingredient required. The affected lots are 26JAN035 with a best use date of 09/07/2026, and 26FEB015 with a best use date of 09/24/2026.

The product was distributed nationwide in the United States. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Healthcare providers and patients should stop using the affected product and contact the recalling firm for further instructions.

The recalled product

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

Manufacturer

ImprimisRx NJ LLC

Category

Drug — Ophthalmic Solution

Hazard

• subpotent-drug

Affected units

772

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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