Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content
Albek De Mexico S.A. De C.V. is recalling NuuxSan hand sanitizer because it contained methanol and had lower ethanol levels than labeled.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of methanol in a consumer product poses a significant risk of serious injury or death if ingested or absorbed, meeting the criteria for a Severe rating.
Plain-English summary
Albek De Mexico S.A. De C.V. is recalling NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol, 8 fl oz. bottles. The recall involves 1,441,548 bottles distributed nationwide in the United States. The product was found to be below the label claim for ethanol content and contained methanol. Other products were also recalled because they were manufactured in the same facility as the product found to contain methanol.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The presence of methanol in hand sanitizer is a safety concern, as methanol can be toxic if absorbed through the skin or ingested. The low ethanol content means the product may not be as effective as labeled.
Consumers should stop using the recalled product and return it to the place of purchase for a refund or follow instructions provided by the recalling firm. The product is identified by UPC 7 13620 00017 5 and was made in Mexico.
The recalled product
- Product
- NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5
- Manufacturer
- Albek De Mexico S.A. De C.V.
- Category
- Drug — Hand Sanitizer
- Hazard
- Affected units
- 1,441,548
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 nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Albek De Mexico S.A. De C.V. 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 5 products in this recall →Related recalls
Same manufacturer · Albek De Mexico S.A. De C.V.
See all →- SevereHand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content
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