Premium Nature Instant Hand Sanitizer — Class II drug recall D-0646-2022
Ongoing recall by AMS Packaging Inc, reported 2022-03-02, distributed nationwide. Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
| Recall number | D-0646-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMS Packaging Inc, South Plainfield, NJ, United States |
| Recall initiated | 2022-01-28 |
| Classified | 2022-03-07 |
| Reported by FDA | 2022-03-02 |
| Distributed | Nationwide (US) |
| Quantity | 2,095,567 bottles |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00819192028262, 00819192028309, 00819192028651, 00819192028743 |
Product
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
Reason for recall
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent 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-0646-2022. 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.