The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1463-2022·Announced 2022-08-31

Maxim Instant Foam Hand Sanitizer recalled due to expired active ingredient

Midlab Incorporated is recalling Maxim Instant Foam Hand Sanitizer nationwide. The product was manufactured using expired benzalkonium chloride, potentially compromising effectiveness.

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: This is an FDA Class II recall involving manufacturing deviations with an expired active ingredient resulting in potential loss of product efficacy. No illnesses, injuries, or hospitalizations have been reported.

Plain-English summary

Midlab Incorporated, located at 140 Private Brand Way, Athens, TN 37303, is recalling Maxim Instant Foam Hand Sanitizer containing benzalkonium chloride 0.1% that was distributed nationwide. The recall includes two package sizes: 1 U.S. Gallon (3.78 Liters) drums with UPC 761841 02502 6 and 55 U.S. Gallon drums (208 Liters) with UPC 007 61841 02504 0. A total of 892 one-gallon drums and one 55-gallon drum are being recalled.

The recall is due to a Current Good Manufacturing Practice (CGMP) deviation. The affected product was manufactured using an expired active ingredient (benzalkonium chloride). The use of an expired active ingredient may result in reduced or loss of product efficacy.

The affected lots include: 03292022-1, 05092022-1, 02012022-1, 06172022-1, 12132021-1, 07272022-1 (for 1-gallon drums), and 06252022-1 (for 55-gallon drums).

Consumers and institutions that received this product should stop using it and contact Midlab Incorporated for instructions on product return or disposal.

The recalled product

Product
Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303
Manufacturer
Midlab Incorporated
Category
Drug — Hand Sanitizer
Hazard

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 (7)

  • Lot #: a) 03292022-1
  • 05092022-1
  • 02012022-1
  • 06172022-1
  • 12132021-1
  • 07272022-1
  • and b) 06252022-1

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Midlab Incorporated 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 2 products in this recall →

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