Povidone-iodine antiseptic solution recalled after testing subpotent in one lot
READYPREP PVP Povidone-Iodine 10% Solution, 1 gallon bottles, lot 24EJA180, is recalled nationwide as a subpotent drug. 2,680 bottles are affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The rubric puts FDA Class III actions at 1 or 2, and this is a potency shortfall with no health hazard described in the notice.
Plain-English summary
READYPREP PVP Povidone-Iodine 10% Solution, a non-sterile topical antiseptic in 1 gallon (3.78 L) bottles, manufactured in the USA by Medline Industries, LP of Northfield, Illinois, NDC 53329-939-25, is being recalled. The affected product is lot 24EJA180 with an expiry of 06/01/2027, and the recall covers 2,680 bottles distributed nationwide.
The recall was issued because the product is subpotent. The FDA classified the action as Class III.
Healthcare facilities holding this lot should stop using it and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- POVIDONE-IODINE (POVIDONE-IODINE)
- Brand
- POVIDONE-IODINE
- Manufacturer
- Medline Industries, LP
- Category
- Drug — Antiseptic
- Affected units
- 2,680
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 24EJA180
- Exp 06/01/2027
Distribution
Distributed nationwide across the United States.
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