Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported January 25, 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 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.
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Southwest Iowa Renewable Energy LLC recalled SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (… — a moderate-severity action.
SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (… was recalled by Southwest Iowa Renewable Energy LLC in January 25, 2023. Reason: CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally,…. Check the official notice for the remedy. Verify recall #D-0166-2023 with the FDA Drug before acting.
The recall
Southwest Iowa Renewable Energy LLC issued this moderate-severity FDA Drug recall — CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally,….
- Moderate
- severity level
- Class II
- classification
- January 25, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0166-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0166-2023) was formally reported on January 25, 2023, with the manufacturer initiating the action on October 6, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Southwest Iowa Renewable Energy LLC is listed as the recalling firm, operating out of Council Bluffs, IA. Federal records list the affected scope as a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles.
The documented reason for this recall is: CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent. Distribution data in the federal record shows the product reached: IA, NE. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Food recalls over time
Where this recall sits in its category — 25,414 food recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0166-2023 |
| Date reported | January 25, 2023 |
| Date initiated | October 6, 2022 |
| Recalling firm | Southwest Iowa Renewable Energy LLC |
| Firm location | Council Bluffs, IA |
| Affected scope | a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles |
| Distribution | IA, NE |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0166-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Southwest Iowa Renewable Energy LLC. Units affected: a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles.
Why was this product recalled? ▼
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2023. Severity: Moderate. Recall number: D-0166-2023.
Where was the recalled product distributed? ▼
Distribution: IA, NE.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0166-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported January 25, 2023.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.