The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1475-2022·Announced 2022-09-07

Luxury Isopropyl Alcohol Recalled for Undeclared Ethyl Alcohol

Luxury 70% Isopropyl Alcohol First Aid Antiseptic is recalled because it contains undeclared ethyl alcohol. The product was distributed in Virginia and affects 350,000 bottles across multiple lot numbers.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA classified this as Class II, indicating potential for adverse health consequences. The product contains an undeclared active ingredient that could affect individuals who must avoid ethanol due to medical conditions, sensitivities, or religious practices. The undeclared nature of the ingredient presents a risk-of-harm situation, though no illnesses or injuries have been reported.

Plain-English summary

Luxury 70% Isopropyl Alcohol First Aid Antiseptic, distributed by TSM Brands LLC, is being recalled because the product contains undeclared ethyl alcohol. The 12 FL. OZ. bottles were not properly labeled with all of their ingredients.

The affected product (UPC 868275965765) was distributed in Virginia. Approximately 350,000 bottles are involved in this recall, spanning lot numbers 015 through 038. The manufacturer is TSM Brands LLC of Manalapan, New Jersey.

Consumers who have purchased this product should discontinue use. Individuals who must avoid ethanol for any reason should be aware that this product contains undeclared ethyl alcohol. Consumers with questions or concerns about exposure to this product should contact their healthcare provider.

The recalled product

Product
Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765.
Manufacturer
Tsm Brands LLC
Category
Drug — Topical Antiseptic
Hazard
Affected units
350,000

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 # 015
  • 016
  • 017
  • 018
  • 019
  • 020
  • 021
  • 022
  • 023
  • 024
  • 025
  • 026
  • 027
  • 028
  • 029
  • 030
  • 031
  • 032
  • 033
  • 034

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Tsm Brands LLC 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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