Medline alcohol prep pads recalled for alcohol below labeled concentration
Medline Alcohol Prep Pads, 70% isopropyl alcohol, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 6,669,874 swabs.
What this means for you
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
Medline Alcohol Prep Pads, 70% isopropyl alcohol, supplied as 100 sterile 2-ply single-use large pads, manufactured for Medline Industries, LP of Northfield, Illinois, NDC 53329-811-30, are being recalled. The affected product carries code 61224040057, and the recall covers 6,669,874 swabs 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.
Healthcare facilities and consumers holding these pads should stop using them for antiseptic purposes and follow the distributor's instructions for return.
The recalled product
- Product
- MEDLINE ALCOHOL PREP (ISOPROPYL ALCOHOL)
- Brand
- MEDLINE ALCOHOL PREP
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Drug — Antiseptic
- Affected units
- 6,669,874
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)
- 61224040057
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 →Related recalls
Same brand · MEDLINE ALCOHOL PREP
- ModerateMedline Alcohol Prep Pads Recalled for Subpotent Isopropyl Alcohol
FDA (Drugs) · 2025-03-26
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