Recalls / Class III
Class IIID-0674-2025
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
- Brand name
- Povidone-iodine
- Generic name
- Povidone-iodine
- Active ingredient
- Povidone-iodine
- Route
- Topical
- NDC
- 53329-939
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot # 24EJA180, Exp 06/01/2027
Why it was recalled
Subpotent drug
Recalling firm
- Firm
- Medline Industries, LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Lakes Dr, N/A, Northfield, Illinois 60093-2753
Distribution
- Quantity
- 2,680 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-08-19
- FDA classified
- 2025-09-24
- Posted by FDA
- 2025-10-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0674-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.