Povidone and Proparacaine Ophthalmic Solution Recalled Due to Drug Subpotency

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class III recall for povidone iodine and proparacaine hydrochloride ophthalmic solution, 10 mL. The affected batches have been identified as Lots 26JAN035 and 26FEB015 (expiring September 2026), containing 772 bottles.
• The recall was initiated by ImprimisRx NJ, LLC due to drug subpotency, a quality issue that is not likely to cause adverse health consequences.
• During medical procedures, povidone iodine is used to prevent eye infections, and proparacaine is used to numb the eye.

The FDA has issued a Class III recall for povidone iodine and proparacaine hydrochloride ophthalmic solution, 10 mL, affecting 772 bottles. This product is being recalled by ImprimisRx NJ, LLC based in Ledgewood, New Jersey. The recall was initiated on August 24, 2026, and received a Class III classification on September 8, 2026. A Class III classification means the use of this product is not likely to cause adverse health consequences.

The recall was initiated due to the presence of a subpotent drug. This deficiency affects Lots 26JAN035 and 26FEB015, which will expire in September 2026. ImprimisRx NJ has sent out a public notice via letter; no press release has been issued for this recall.

Povidone iodine is used to disinfect the eye during surgery to prevent infection. Proparacaine is a local aesthetic used to numb the eye before a procedure. Pharmacists should identify and quarantine Lots 26JAN035 and 26FEB015, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. September 16, 2026. Accessed September 16, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222413