SIREtizer Hand Sanitizer — Class II drug recall D-0166-2023
Ongoing recall by Southwest Iowa Renewable Energy LLC, reported 2023-01-25, distributed in IA, NE. CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally,
| Recall number | D-0166-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Southwest Iowa Renewable Energy LLC, Council Bluffs, IA, United States |
| Recall initiated | 2022-10-06 |
| Classified | 2023-01-19 |
| Reported by FDA | 2023-01-25 |
| Distributed | IA, NE |
| Reason classes | potency, cgmp |
| UPC / GTIN / UDI-DI | 00860003858806, 00860003858820 |
| Lot numbers | 0001, 0005, 0007 |
Product
SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Beverages, LLC, Lincoln, NE 68522 and Bottled by South Tenth Development, LLC, Lincoln, NE 68522.
Reason for recall
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
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-0166-2023. 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.