Alcohol Antiseptic 80% Topical Solution Hand Sanitizer — Class II drug recall D-0092-2023
Completed recall by NCH Life Sciences LLC, reported 2023-01-04, distributed nationwide. CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed lim
| Recall number | D-0092-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | NCH Life Sciences LLC, Irving, TX, United States |
| Recall initiated | 2022-12-09 |
| Classified | 2022-12-28 |
| Reported by FDA | 2023-01-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 10,930 gallons |
| Reason classes | cgmp, specification failure |
| NDC | 55533-0524-02, 55533-0524-03 |
| Lot numbers | 12013501, 12013505, 12013510, 12014113, 12014282, 12014804, 12015401, 12032504, 12032523, 12104039 |
Product
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062
Reason for recall
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
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-0092-2023. 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.