CLASS III Drug recall · Reported 16 Mar 2016 · FDA Enforcement Report

Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution recalled

Ecolab is recalling Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, distributed nationwide in the US. The recall was initiated on 12 Feb 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: a) L041051, Exp 04 /17; L060151, L061951, Exp 06 /17; b) L060151, L061951, Exp 06 /17

NDC47593-468

Quantity recalled706 bottles

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-0766-2016
FDA event ID: 73264
Recalling firm: Ecolab, Saint Paul, MN
Brand: Scrub-stat
Manufacturer: Ecolab Inc.
Classification: Class III
Status: Terminated
Recall initiated: 12 Feb 2016
FDA classified: 8 Mar 2016
Reported: 16 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

12 Feb 2016	Recall initiated by company
8 Mar 2016	Classified by FDA	+25 days
16 Mar 2016	Published in enforcement report	+8 days

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

Reason for recall

Subpotent drug

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102

Where it was distributed

Nationwide, Puerto Rico and Canada

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Subpotent drug

Which lots are affected?

Lot #: a) L041051, Exp 04 /17; L060151, L061951, Exp 06 /17; b) L060151, L061951, Exp 06 /17

Where was it sold?

Nationwide, Puerto Rico and Canada

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

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Other Chlorhexidine Gluconate recalls

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9 Sep 2026Drug	CLASS II	2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate	Sage Products	Other	Nationwide
22 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide