FDA Drug recall D-0166-2023
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…
- FDA Drug
- Class II
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class II recall of 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… by Southwest Iowa Renewable Energy, citing CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0166-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-06 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Southwest Iowa Renewable Energy |
| Distribution | IA, NE |
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
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Identifiers
| upc | 860003858820 |
|---|---|
| upc | 860003858806 |
| code_info | Lots: 0001, 0005, 0007 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0166-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.