CLASS II ONGOING Drug recall · Reported 25 Jan 2023 · FDA Enforcement Report
SIREtizer Hand Sanitizer (Ethyl Alcohol) recalled
Southwest Iowa Renewable Energy is recalling SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, distributed in Iowa, Nebraska. The recall was initiated on 6 Oct 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0166-2023
- FDA event ID
- 90953
- Recalling firm
- Southwest Iowa Renewable Energy, Council Bluffs, IA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Oct 2022
- FDA classified
- 19 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Hand Sanitizer
Timeline
| 6 Oct 2022 | Recall initiated by company | |
| 19 Jan 2023 | Classified by FDA | +105 days |
| 25 Jan 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
IA, NE
Questions about this recall
Why was it recalled?
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Which lots are affected?
Lots: 0001, 0005, 0007
Where was it sold?
IA, NE
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.