CLASS I Drug recall · Reported 21 Apr 2021 · FDA Enforcement Report
Lite'n Foamy Lemon Blossom Hand Sanitizer recalled
Spartan Chemical is recalling Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: per, distributed nationwide in the US. The recall was initiated on 29 Mar 2021 and the FDA has classified it as Class I.
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-0359-2021
- FDA event ID
- 87633
- Recalling firm
- Spartan Chemical, Maumee, OH
- Classification
- Class I
- 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
- Sterility
- Drug class
- Hand Sanitizer
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
Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26288 5 SKU# 333806 NDC: 64009-331-82
Where it was distributed
Nationwide USA and Puerto Rico; Mexico
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Which lots are affected?
Lot 538305, exp 1/14/2023
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 E2 Sanitizing Handwash (Benzalkonium Chloride recalledLite Nfoamy E2 Sanitizing Handwash | 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 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 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 | Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride recalledLite Nfoamy E2 Sanitizing 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 |