Drug recall: Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, N

FDA enforcement event 86246 · Class II · initiated 30 Jul 2020 · status Terminated · terminated 19 May 2023

DrugVoluntary: Firm initiated1 product recordSaint Paul, MN

FDA enforcement event 86246 is a drug recall by Ecolab Inc of Saint Paul, MN, initiated 30 Jul 2020 and classified Class II, with 1 product record.

FDA defines Class II as 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. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 19 May 2023. Initiation: voluntary: firm initiated. Ecolab Inc has 14 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Ecolab Inc, Saint Paul, MN.

Reason for recall

"Discoloration and Presence of Foreign Substance"

Distribution

"Nationwide within the United States"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1539-2020	Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21	305 drums	Class II	Terminated	2 Sep 2020

Context

64%of 2020 drug events are Class II342 events that year

1product record in this eventfirm median: 1

14events on this register for the firm

Other enforcement events for Ecolab Inc

Initiated	Product (first record)	Type	Class	Records
11 Jan 2021	Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended	Device	Class II	1
10 May 2019	QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Pa	Drug	Class III	1
6 Feb 2019	Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz	Drug	Class II	5
9 Nov 2018	Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street	Drug	Class II	2
14 Sep 2018	Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Int	Device	Class II	4
22 Nov 2017	ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/	Device	Class III	2
13 Oct 2017	Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches a	Device	Class II	1
2 Dec 2016	Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-	Drug	Class III	1
30 Nov 2016	Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.	Device	Class III	1
14 Jul 2016	Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shi	Device	Class II	1

All 14 events for Ecolab Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Discoloration and Presence of Foreign Substance"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide within the United States"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 19 May 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.