FDA Recall D-0674-2025
Medline Industries, LP · Northfield, IL
Class III Ongoing 268 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25
Reason for recall
Subpotent drug
Recall record
- Recall number
D-0674-2025- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2025-08-19
- Classified by FDA Center
- 2025-09-24
- FDA published
- 2025-10-01
- Recalling firm
- Medline Industries, LP
- Firm location
- Northfield, IL
Drug identification
- Brand name(s)
- POVIDONE-IODINE
- Generic name(s)
- POVIDONE-IODINE
- Manufacturer(s)
- Medline Industries, LP
- NDC(s)
53329-939- Route(s)
- TOPICAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.