M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v — Class I drug recall D-1342-2022
Terminated recall by MEDEK LLC, reported 2022-08-24, distributed in TX. Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label clai
| Recall number | D-1342-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDEK LLC, Alamo, TX, United States |
| Recall initiated | 2020-09-09 |
| Classified | 2022-08-15 |
| Reported by FDA | 2022-08-24 |
| Terminated | 2024-08-23 |
| Distributed | TX |
| Quantity | 256 bottles |
| Reason classes | chemical contamination, labeling, potency |
| NDC | 75432-0001-02, 77797-0001-01 |
Product
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX 78516, NDC Code: 75432-001-02.
Reason for recall
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
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-1342-2022. 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.