PlainRecalls
FDA Drug Verify with FDA Drug → Moderate Class II Terminated

INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.

Reported: June 5, 2019 Initiated: April 22, 2019 #D-1314-2019 17,850 pounds per batch units

Inopak Ltd issued this FDA Drug recall on June 5, 2019. Classified as Moderate severity (Class II). Approximately 17,850 pounds per batch units are affected. The recall was issued because: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Drug action (record #D-1314-2019) was formally reported on June 5, 2019, with the manufacturer initiating the action on April 22, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Inopak Ltd is listed as the recalling firm, operating out of Ringwood, NJ. Federal records indicate 17,850 pounds per batch units are affected.

The documented reason for this recall is: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

17,850 pounds per batch

Related Recalls

6

0 from same agency

Product Description

INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.

Reason for Recall

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

Details

Recalling Firm
Inopak Ltd
Units Affected
17,850 pounds per batch
Distribution
Nationwide in the USA
Location
Ringwood, NJ

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-1314-2019
Date reported June 5, 2019
Date initiated April 22, 2019
Recalling firm Inopak Ltd
Units affected 17,850 pounds per batch
Distribution Nationwide in the USA

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

17,850 pounds per batch units affected — limited or regional distribution scale.

Regional (<10K units)
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.. Recalled by Inopak Ltd. Units affected: 17,850 pounds per batch.
Why was this product recalled?
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 5, 2019. Severity: Moderate. Recall number: D-1314-2019.
Where was the recalled product distributed?
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1314-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Lowes Foods sour cream and onion flavored potato chips, 8oz… →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).