The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1564-2019·Announced 2019-08-07

Lemon Hand Sanitizer Recalled for Missing Stability Testing

NingBo Huize Commodity Co., Ltd. is recalling Lemon Hand Sanitizer because stability testing was not conducted on the product.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a documentation/testing deviation rather than a direct safety hazard.

Plain-English summary

NingBo Huize Commodity Co., Ltd. is recalling Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China. The recall involves 126,500 units distributed to seven consignees located in China.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, stability testing was not conducted on the manufactured sunscreen and hand sanitizer OTC products. The agency has classified this recall as Class III.

Consumers should check their inventory for the affected lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the point of purchase or disposed of according to local regulations.

The recalled product

Product
Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.
Manufacturer
NingBo Huize Commodity Co.,Ltd.
Category
Drug — OTC Hand Sanitizer
Hazard
Affected units
126,500

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 (20)

  • Lot #: 20170410
  • Exp 04/09/2019
  • 20170515
  • Exp 05/14/2019
  • 20170516
  • Exp 05/15/2019
  • 20170517
  • Exp 05/16/2019
  • 20170518
  • Exp 05/17/2019
  • 20170519
  • Exp 05/18/2019
  • 20170522
  • Exp 05/21/2019
  • 20170523
  • Exp 05/22/2019: 20170524
  • Exp 05/23/2019
  • 20170525
  • Exp 05/24/2019
  • 20170526

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 36 recalled by NingBo Huize Commodity Co.,Ltd. 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 36 products in this recall →

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