AMS Packaging Premium Nature Instant Hand Sanitizer Recall

Why it was recalled

Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

Product description

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.

Lot numbers, UPCs & expiration codes

All lots within expiry and labelled as 'Made in the USA'

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0647-2022
Classification: Class II
Status: Ongoing
Recall initiated: Jan 28, 2022
FDA report date: Mar 2, 2022
Quantity: 487,000 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: AMS Packaging Inc

Original FDA data

Every field from FDA enforcement report D-0647-2022, exactly as published.

Show all FDA fields

City: South Plainfield
State: NJ
Status: Ongoing
Country: United States
Event ID: 89503
Address: 161 Helen St
Code information: All lots within expiry and labelled as 'Made in the USA'
Postal code: 07080-3806
Report date: Mar 2, 2022
Product type: Drugs
Recall number: D-0647-2022
Classification: Class II
Recalling firm: AMS Packaging Inc
Product quantity: 487,000 bottles
Reason for recall: Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.
Distribution pattern: Nationwide in the USA
Recall initiation date: Jan 28, 2022
Initial firm notification: E-Mail
Center classification date: Mar 7, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0647-2022, published Mar 2, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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