CLASS III Drug recall · Reported 8 Feb 2017 · FDA Enforcement Report
Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam recalled by Ecolab
Ecolab is recalling Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, distributed in Puerto Rico. The recall was initiated on 2 Dec 2016 and the FDA has classified it as Class III.
Check your package
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-0454-2017
- FDA event ID
- 76177
- Recalling firm
- Ecolab, Huntington, IN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Dec 2016
- FDA classified
- 31 Jan 2017
- Reported
- 8 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 2 Dec 2016 | Recall initiated by company | |
| 31 Jan 2017 | Classified by FDA | +60 days |
| 8 Feb 2017 | 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
Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Number: 61430436 (800 mL, 12 bottles/case) - United States; Model Number: 6000179 (800 mL, 12 bottles/case) - Canada, Ecolab, St. Paul, MN 55102, NDC 47593-265-36
Where it was distributed
United States, Puerto Rico and Canada
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot # L050261, Exp 05/18
Where was it sold?
United States, 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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