BORN BASIC — Class II drug recall D-1581-2020
Terminated recall by Real Clean Distribuciones SA de CV, reported 2020-09-23, distributed nationwide. CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained m
| Recall number | D-1581-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Real Clean Distribuciones SA de CV, Tlalnepantla De Baz, N/A, Mexico |
| Recall initiated | 2020-07-23 |
| Classified | 2020-09-11 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2022-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 975,720 bottles |
| Reason classes | chemical contamination, labeling, cgmp |
| UPC / GTIN / UDI-DI | 00840038214471, 00840038214563, 00840038214624 |
Product
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
Reason for recall
CGMP Deviations: Born Basic Anti Bac 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-1581-2020. 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.