CLASS II Drug recall · Reported 2 Sep 2020 · FDA Enforcement Report

Hand Sanitizer (Alcohol 80% v/v) topical solution recalled by Ecolab

Ecolab is recalling Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL EcoLab Inc 1 EcoLab Place, distributed nationwide in the US. The recall was initiated on 30 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: BP0D3091A0, BP0D3203A0, CR0D0553A0, CR0D0571A0, CR0D0577A0, CR0D0584A0, CR0E0482A0, CR0E0490A0, CR0E0499A0, CR0E0501A0, CR0E0520A0, FO0D0358A0, FO0D0440A0, FO0D0456A0, FO0D0464A0, FO0D0480A1, FO0D0490A0, FO0D0502A1, FO0D0517A1, FO0E0044A1, FO0E0061A1, FO0E0075A1, FO0E0094A0, FO0E0111A0, FO0E0119A1, FO0E0241A1, FO0E0256A1; Exp. Date April 2021

Quantity recalled305 drums

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1539-2020
FDA event ID: 86246
Recalling firm: Ecolab, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 30 Jul 2020
FDA classified: 24 Aug 2020
Reported: 2 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Drug class: Creams, Ointments & Gels

Timeline

30 Jul 2020	Recall initiated by company
24 Aug 2020	Classified by FDA	+25 days
2 Sep 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Discoloration and Presence of Foreign Substance

Product as listed by the FDA

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

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Discoloration and Presence of Foreign Substance

Which lots are affected?

Lot #: BP0D3091A0, BP0D3203A0, CR0D0553A0, CR0D0571A0, CR0D0577A0, CR0D0584A0, CR0E0482A0, CR0E0490A0, CR0E0499A0, CR0E0501A0, CR0E0520A0, FO0D0358A0, FO0D0440A0, FO0D0456A0, FO0D0464A0, FO0D0480A1, FO0D0490A0, FO0D0502A1, FO0D0517A1, FO0E0044A1, FO0E0061A1, FO0E0075A1, FO0E0094A0, FO0E0111A0, FO0E0119A1, FO0E0241A1, FO0E0256A1; Exp. Date April 2021

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ecolab

All 28

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3 Mar 2021Device	CLASS II	Slush + Warmer Disc Drape recalled by Ecolab	Ecolab	Sterility	Nationwide
26 Jun 2019Drug	CLASS III	Quik-care Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol) recalledQuik-care	Ecolab	Labeling Errors	Nationwide
3 Apr 2019Drug	CLASS II	Gel Hand Sanitizer (Ethyl Alcohol 70%) recalled by EcolabEcolab	Ecolab	Benzene	Nationwide
3 Apr 2019Drug	CLASS II	Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), Ecolab recalled	Ecolab	Benzene	Nationwide
3 Apr 2019Drug	CLASS II	Advanced Gel Hand Sanitizer (Ethyl alcohol 62%) recalled by EcolabAdvanced Gel Hand Sanitizer	Ecolab	Benzene	Nationwide