Recall for READYPREP Povidone-Iodine Solution Due to Subpotency

The US Food and Drug Administration (FDA) has announced a Class III recall for READYPREP PVP Povidone-Iodine 10% Solution, a 1-gallon topical antiseptic product manufactured by Medline Industries, LP in Northfield, Illinois. The recall involves 2680 bottles from Lot #24EJA180, which carries an expiration date of June 1, 2027. The product was found to be subpotent, meaning it did not meet the specified concentration of active ingredients required to ensure its full antimicrobial effectiveness. The recall was voluntarily initiated on August 19, 2025, with distribution across the United States.

The FDA classified the recall as Class III on September 24, 2025, indicating that use of the affected product is not likely to cause adverse health consequences, but the deviation from potency standards warrants removal from the market. While no contamination or serious safety risk has been identified, subpotent antiseptic products may deliver reduced efficacy in preoperative or wound care scenarios, especially in clinical environments that rely on consistent antimicrobial performance. 

READYPREP PVP is a non-sterile topical antiseptic used in health care settings to clean skin prior to procedures and reduce bacterial presence. As a povidone-iodine formulation, it is commonly used in surgical prep and wound care to prevent infection. Pharmacists and health care facility staff should identify and remove affected lot #24EJA180 from storage or clinical use, and ensure that alternative antiseptic solutions are available for uninterrupted patient care. 

Reference
FDA. Enforcement Report. October 1, 2025. Accessed October 1, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=215746