The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0363-2021·Announced 2021-04-21

Spartan Chemical Recalls Lite'n Foamy Handwash Due to Manufacturing Deviations

Spartan Chemical Co Inc is voluntarily recalling 1,200 cases of Lite'n Foamy Eucalyptus Mint Sanitizing Handwash due to Current Good Manufacturing Practice (CGMP) deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations, which aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/manufacturing errors without reported serious injury.

Plain-English summary

Spartan Chemical Co Inc has voluntarily initiated a recall of 1,200 cases of Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%). The product is sold in 18 oz/532 ml foam pump containers intended for institutional and industrial use only. The specific lot affected is Lot 538307, with an expiration date of 1/20/2023.

The recall was initiated on March 29, 2021, due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this recall as Class II, which indicates a situation in which there is a reasonable probability that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide in the United States and Puerto Rico, as well as in Mexico. Consumers and institutions should stop using the product and contact Spartan Chemical Co Inc for further instructions or a refund.

The recalled product

Product
LITE NFOAMY EUCALYPTUS MINT SANITIZING HANDWASH (BENZALKONIUM CHLORIDE)
Brand
LITE NFOAMY EUCALYPTUS MINT SANITIZING HANDWASH
Manufacturer
Spartan Chemical Co Inc
Category
Drug — OTC Drug
Hazard
Affected units
1,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot
  • expiry: Lot 538307
  • exp 1/20/2023

UPCs (1)

  • 0753727261109

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Spartan Chemical Co Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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