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
Affected units
256

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

Distributed in 1 state:

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