Alcohol prep pads recalled from one lot as a subpotent drug
Medline is recalling 222,800 alcohol prep pads from one lot because the product is subpotent.
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: Scored 3 under the risk-of-harm criterion: a subpotent antiseptic may not disinfect skin as labeled, creating an infection risk, with no injuries reported.
Plain-English summary
Medline Alcohol Prep Pads, 2-ply pads with 70% isopropyl alcohol, 100 per box and 10 boxes per case, single use only, carrying NDC 55329-811-30, are being recalled as a subpotent drug.
The recall covers 222,800 eaches from lot 61224040057, distributed nationwide in the United States. The FDA has classified the recall as Class II.
Subpotency means the pads contain less alcohol than the label states, so they may not disinfect skin as intended before a procedure. The enforcement record reports no injuries.
Facilities holding the affected lot should quarantine it and follow Medline's instructions.
The recalled product
- Product
- Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.
- Manufacturer
- Medline Industries, LP
- Category
- Drug — Antiseptic
- Affected units
- 222,800
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)
- Lot #: 61224040057
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medline Industries, LP
See all →- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to overpressure alerts
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
- SevereMedline surgical kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
Same hazard · subpotent
See all →- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- HighCompounded vasopressin syringes recalled as subpotent by IntegraDose Compounding Services
FDA (Drugs) · 2026-06-24
- ModerateSkin Rehab calming hydrocortisone balm recalled as a subpotent drug
FDA (Drugs) · 2026-04-22
- Moderateglo Skin Beauty Remedy Gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22
- ModerateRhonda Allison calming skin gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22
Similar recalls
- ModerateMedline Alcohol Prep Pads Recalled for Subpotent Isopropyl Alcohol
FDA (Drugs) · 2025-03-26
- HighMedline alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighFDA Recalls Subpotent CURAD Alcohol Prep Pads Nationwide
FDA (Drugs) · 2025-03-26
- HighCURAD alcohol prep pads recalled for isopropyl alcohol below labeled strength
FDA (Drugs) · 2025-09-03
- SevereMedline Recalls Subpotent Povidone-Iodine Prep Pads
FDA (Drugs) · 2018-02-07
- ModerateMedline Newborn Kit Recalled for Subpotent Povidone-Iodine Prep Pads
FDA (Drugs) · 2018-02-07