The Recall Desk
CriticalFDA (Drugs)·D-1342-2022·Announced 2022-08-24

Hand sanitizer recalled for methanol contamination and insufficient ethanol

Medek LLC is recalling M Hand Sanitizer due to FDA analysis finding methanol contamination and ethanol levels below label claims. Approximately 256 bottles distributed in Texas.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This recall is classified as FDA Class I, which meets the Critical severity threshold. The product contains methanol and has ethanol levels below label claims.

Plain-English summary

M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v is being recalled. The 128 oz bottles were manufactured in Mexico by Grupo Plast-Y-Kosas S.A. de C.V. and distributed in Texas by Medek LLC.

FDA analysis found that the product contains methanol and has ethanol levels below the 80% concentration stated on the label. Approximately 256 bottles were distributed, affecting all lot numbers.

The recalled product

Product
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX
Manufacturer
MEDEK LLC
Category
Drug — Topical Antiseptic
Hazard
  • methanol
  • subpotent

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

Distribution

Distribution scope not specified by the agency.

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