Incontrol Alcohol Swab
FDA Recall NDC 37808-809
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Incontrol Alcohol (NDC 37808-809). A significant event, classified as Class II, was initiated on Jul 07, 2025 by H-e-b. The reported reason for this action was: "Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
July 2025 Class II Recall: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Recall Number
Class II Ongoing
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Jul 07, 2025
Sep 03, 2025
300000 pads
Recall Profile & Regulatory Data
Event ID
97385
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# 61224080041
Affected Packages Involved in this Recall
37808-809-30Product
37808-809-60Product
37808-809-09Product
6122408004Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
