The Recall Desk
ModerateFDA (Drugs)·D-0647-2022·Announced 2022-03-02

Premium Nature Instant Hand Sanitizer Recalled for Subpotent Ethanol

AMS Packaging Inc is recalling Premium Nature Instant Hand Sanitizer (70% ethyl alcohol) in 8 oz and 16 oz bottles because some bottles contain less ethanol than labeled, reducing effectiveness.

What this means for you

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 with no reported illness or injury. The hazard is subpotency—reduced antimicrobial effectiveness—which is a labeling and formulation issue that creates theoretical risk but with no documented harm to consumers reported in the source text.

Plain-English summary

AMS Packaging Inc is recalling Premium Nature Instant Hand Sanitizer distributed nationwide in the USA. The product is sold in 8 ounce bottles (UPC 8 19192 02866 8) and 16 ounce bottles (UPC 8 19192 02874 3), labeled as containing 70% ethyl alcohol.

FDA analysis revealed that some bottles of this hand sanitizer were subpotent for ethanol, meaning they contained less active ingredient than stated on the label. This reduces the product's antimicrobial effectiveness.

Consumers who have purchased this product should stop using it and dispose of it safely, or contact the manufacturer for guidance. Affected lots include all bottles within expiry labeled as "Made in the USA" from Premium Nature, South Plainfield, NJ. A total of approximately 487,000 bottles are affected by this recall.

The recalled product

Product
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.
Manufacturer
AMS Packaging Inc
Hazard
  • subpotent-active-ingredient
  • mis-labeling

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 (1)

  • All lots within expiry and labelled as 'Made in the USA'

Distribution

Distributed nationwide across the United States.