CLASS II ONGOING Drug recall · Reported 25 Nov 2020 · FDA Enforcement Report
NuuxSan Instant Antibacterial Hand Sanitizer recalled
Albek De Mexico is recalling NuuxSan Instant Antibacterial Hand Sanitizer, 70% Ethyl Alcohol (ethyl alcohol 70%), distributed nationwide in the US. The recall was initiated on 30 Jul 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0078-2021
- FDA event ID
- 86162
- Recalling firm
- Albek De Mexico, San Juan Del Rio, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jul 2020
- FDA classified
- 17 Nov 2020
- Reported
- 25 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Hand Sanitizer
Timeline
| 30 Jul 2020 | Recall initiated by company | |
| 17 Nov 2020 | Classified by FDA | +110 days |
| 25 Nov 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Which lots are affected?
all lots
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 86162This product is part of a recall event; the main page for the event is Assured Instant Hand Sanitizer Aloe & Moisturizers recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Assured Instant Hand Sanitizer Aloe & Moisturizers recalled | Albek De Mexico | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Modesa Instant Hand Sanitizer with Moisturizers recalled | Albek De Mexico | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Next Advanced Antibacterial Hand Sanitizer (Ethyl Alcohol 70%) recalled | Albek De Mexico | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Assured Instant Hand Sanitizer Vitamin E and Aloe recalled | Albek De Mexico | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Albek De Mexico
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Assured Instant Hand Sanitizer Vitamin E and Aloe recalled | Albek De Mexico | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Next Advanced Antibacterial Hand Sanitizer (Ethyl Alcohol 70%) recalled | Albek De Mexico | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Modesa Instant Hand Sanitizer with Moisturizers recalled | Albek De Mexico | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Assured Instant Hand Sanitizer Aloe & Moisturizers recalled | Albek De Mexico | Manufacturing (CGMP) Deviations | Nationwide |