Assured Instant Hand Sanitizer Vitamin E and Aloe — Class II drug recall D-0081-2021
Ongoing recall by Albek De Mexico S.A. De C.V., reported 2020-11-25, distributed nationwide. CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol
| Recall number | D-0081-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Albek De Mexico S.A. De C.V., San Juan Del Rio, N/A, Mexico |
| Recall initiated | 2020-07-30 |
| Classified | 2020-11-17 |
| Reported by FDA | 2020-11-25 |
| Distributed | Nationwide (US) |
| Quantity | 19,992 bottles |
| Reason classes | chemical contamination, labeling, cgmp |
| UPC / GTIN / UDI-DI | 00639277928597 |
Product
Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0081-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.