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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- 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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