FDA Recall D-0603-2025
MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL
Class II Ongoing 311 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
Reason for recall
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Recall record
- Recall number
D-0603-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2025-07-07
- Classified by FDA Center
- 2025-08-26
- FDA published
- 2025-09-03
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Firm location
- Northfield, IL
Drug identification
- Brand name(s)
- INCONTROL ALCOHOL
- Generic name(s)
- ISOPROPYL ALCOHOL
- Manufacturer(s)
- H-E-B
- NDC(s)
37808-809- Route(s)
- TOPICAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.