Agency classClass IIOur severity:High FDA (Drugs)·D-0603-2025·Announced 2025-09-03

H-E-B alcohol pads recalled for isopropyl alcohol below labeled concentration

H-E-B inControl Sterile Alcohol Pads, 100 per container, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 300,000 pads.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an antiseptic below its labeled strength may not disinfect as intended and no injuries are reported.

Plain-English summary

H-E-B inControl Sterile Alcohol Pads, containing 100 pads, packaged in China with components from Taiwan for H-E-B of San Antonio, Texas, NDC 37808-809-09, are being recalled. The affected product carries code 61224080041, and the recall covers 300,000 pads distributed nationwide.

The recall was issued because the product is subpotent: isopropyl alcohol levels fall below the labeled concentration. The FDA classified the action as Class II.

Anyone holding these pads should stop using them for antiseptic purposes and can return them to the place of purchase.

The recalled product

Product: INCONTROL ALCOHOL (ISOPROPYL ALCOHOL)
Brand: INCONTROL ALCOHOL
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Drug — Antiseptic
Hazard: subpotency
antiseptic
class-ii
Affected units: 300,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

61224080041

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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