ASSURED Instant Hand Sanitizer Aloe & Moisturizers — Class II drug recall D-0027-2021
Terminated recall by 4e Brands North America, Llc, reported 2020-10-07, distributed nationwide. CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain met
| Recall number | D-0027-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 4e Brands North America, Llc, San Antonio, TX, United States |
| Recall initiated | 2020-07-11 |
| Classified | 2020-10-07 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2024-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 17,359,247 bottles |
| Reason classes | chemical contamination, cgmp |
| UPC / GTIN / UDI-DI | 00639277490704 |
Product
ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico
Reason for recall
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
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-0027-2021. 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.