Recalls / Class II
Class IID-0603-2025
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.
- Brand name
- Incontrol Alcohol
- Generic name
- Isopropyl Alcohol
- Active ingredient
- Isopropyl Alcohol
- Route
- Topical
- NDC
- 37808-809
- FDA application
- M003
- Affected lot / code info
- 61224080041
Why it was recalled
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Recalling firm
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Manufacturer
- H-E-B
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Quantity
- 300000 pads
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-07-07
- FDA classified
- 2025-08-26
- Posted by FDA
- 2025-09-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0603-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.