The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1318-2019·Announced 2019-06-05

Inopak Antibacterial Hand Soap Recalled for CGMP Deviations

Inopak Ltd is recalling specific batches of Antibacterial Hand Soap because they were not produced under current good manufacturing practices.

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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Inopak Ltd is recalling specific batches of Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers and Choice Antibacterial Hand Soap. The recall covers various package sizes, including 1000 ml, 800 ml, and 500 ml pouches, as well as 8 oz and 18 oz bottles. The affected batches are identified by specific batch numbers listed in the recall notice, with each batch weighing 17,850 pounds.

The recall was initiated because the hand sanitizers and soaps were not produced under current good manufacturing practices (CGMP). The product was distributed nationwide in the USA. No specific illnesses or injuries are reported in the source text.

Consumers should check their inventory for the specific batch numbers listed in the official 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
Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches…
Manufacturer
Inopak Ltd
Category
Drug — Hand Soap
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 (20)

  • Batch #: 6660
  • 6664
  • 6676
  • 6682
  • 6685
  • 6698
  • 6701
  • 6725
  • 6732
  • 6742
  • 6744
  • 6746
  • 6756
  • 6762
  • 6770
  • 6777
  • 6792
  • 6798
  • 6807
  • 6813

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Inopak 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 10 products in this recall →

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