The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1474-2022·Announced 2022-09-07

Isopropyl Alcohol Product Contains Undeclared Ethyl Alcohol

Luxury 70% Isopropyl Alcohol distributed in Virginia by TSM Brands LLC contains undeclared ethyl alcohol, creating a mislabeling hazard. Consumers should stop using the product.

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: FDA Class II recall involving mislabeling with an undeclared ingredient. No illnesses or injuries have been reported. The hazard is documented but theoretical without reported harm.

Plain-English summary

TSM Brands LLC is recalling Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (473 mL), due to the presence of undeclared ethyl alcohol in the product. The product label does not disclose ethyl alcohol as an ingredient, creating a mislabeling hazard for consumers.

The affected product was distributed in Virginia. Approximately 2,700,000 bottles are subject to recall, identified by lot numbers 235 through 338. The product carries UPC 868275965734.

Consumers who have purchased this product should stop using it immediately. The product should not be used as labeled. Consumers with questions or who possess affected product should contact TSM Brands LLC at 540 Equinox Lane, Manalapan, NJ 07726.

The recalled product

Product
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
Manufacturer
Tsm Brands LLC
Category
Drug — Topical Disinfectant
Hazard
Affected units
2,700,000

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 # 235
  • 236
  • 237
  • 238
  • 239
  • 240
  • 241
  • 242
  • 243
  • 244
  • 245
  • 246
  • 247
  • 248
  • 249
  • 250
  • 251
  • 252
  • 253
  • 254

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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