Inopak Sani-Guard-SF Waterless Foam Hand Sanitizer Recall

Why it was recalled

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Product description

Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD

Lot numbers, UPCs & expiration codes

Batch #: 6668, 6721

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-1317-2019
Classification: Class II
Status: Terminated
Recall initiated: Apr 22, 2019
FDA report date: Jun 5, 2019
Quantity: 17,850 pounds per batch
Recall type: Voluntary: Firm initiated
Recalling firm: Inopak Ltd

Original FDA data

Every field from FDA enforcement report D-1317-2019, exactly as published.

Show all FDA fields

City: Ringwood
State: NJ
Status: Terminated
Country: United States
Event ID: 82645
Address: 24 Executive Pkwy
Code information: Batch #: 6668, 6721
Postal code: 07456-1430
Report date: Jun 5, 2019
Product type: Drugs
Recall number: D-1317-2019
Classification: Class II
Recalling firm: Inopak Ltd
Product quantity: 17,850 pounds per batch
Termination date: Aug 28, 2024
Reason for recall: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
Distribution pattern: Nationwide in the USA
Recall initiation date: Apr 22, 2019
Initial firm notification: Letter
Center classification date: May 29, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1317-2019, published Jun 5, 2019. 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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