CLASS II Drug recall · Reported 21 Apr 2021 · FDA Enforcement Report
Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride recalled
Spartan Chemical is recalling Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US, distributed nationwide in the US. The recall was initiated on 29 Mar 2021 and the FDA has classified it as Class II.
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-0362-2021
- FDA event ID
- 87633
- Recalling firm
- Spartan Chemical, Maumee, OH
- Manufacturer
- Spartan Chemical Company, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Mar 2021
- FDA classified
- 30 Apr 2021
- Reported
- 21 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 29 Mar 2021 | Recall initiated by company | |
| 21 Apr 2021 | Published in enforcement report | +23 days |
| 30 Apr 2021 | Classified by FDA | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26116 1 NDC: 64009-333-95
Where it was distributed
Nationwide USA and Puerto Rico; Mexico
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot, expiry: Lot 538882, exp 1/22/2023
Where was it sold?
Nationwide USA and Puerto Rico; Mexico
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.
Other products in this recall event
5 other products · FDA event 87633This product is part of a recall event; the main page for the event is foamyiQ Lemon Blossom Hand Sanitizer recalled by Spartan Chemical Co.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | foamyiQ Lemon Blossom Hand Sanitizer recalled by Spartan Chemical Co | Spartan Chemical | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol recalledLite Nfoamy Healthcare Personnel Handwash | Spartan Chemical | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents recalledAntiseptic Hand Cleaner | Spartan Chemical | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS I | Lite'n Foamy Lemon Blossom Hand Sanitizer recalled | Spartan Chemical | Sterility | Nationwide | |
| CLASS II | Lite'n Foamy Eucalyptus Mint Sanitizing Handwash recalledLite Nfoamy Eucalyptus Mint Sanitizing Handwash | Spartan Chemical | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Spartan Chemical
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lite'n Foamy Eucalyptus Mint Sanitizing Handwash recalledLite Nfoamy Eucalyptus Mint Sanitizing Handwash | Spartan Chemical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Lite'n Foamy Lemon Blossom Hand Sanitizer recalled | Spartan Chemical | Sterility | Nationwide |
| Drug | CLASS II | Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents recalledAntiseptic Hand Cleaner | Spartan Chemical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol recalledLite Nfoamy Healthcare Personnel Handwash | Spartan Chemical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | foamyiQ Lemon Blossom Hand Sanitizer recalled by Spartan Chemical Co | Spartan Chemical | Manufacturing (CGMP) Deviations | Nationwide |
Other Benzalkonium Chloride recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cleansing Towelette (Benzalkonium Chloride 0.13%) recalledMed Nap Cleansing Towelette | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%) recalledGreen Guard Antiseptic Wipes | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Medi-First Antiseptic Wipes recalled by Acme UnitedMedi-first Antiseptic Wipes | Acme United | Manufacturing (CGMP) Deviations | Nationwide |