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

Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

Reported: February 14, 2024 Initiated: January 19, 2024 #D-0288-2024 4390 vials units

The recall

Omeza LLC issued this moderate-severity FDA Drug recall — CGMP Deviations.

Moderate
severity level
4390 vials
units affected
Class II
classification
February 14, 2024
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0288-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0288-2024) was formally reported on February 14, 2024, with the manufacturer initiating the action on January 19, 2024. It is classified under Moderate severity (Class II), with a current status of Terminated. Omeza LLC is listed as the recalling firm, operating out of Sarasota, FL. Federal records indicate 4390 vials units are affected.

The documented reason for this recall is: CGMP Deviations Distribution data in the federal record shows the product reached: US Nationwide. 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 and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. 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 2 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.

Where this recall sits in the database

Severity2119858883High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.

Severity

Moderate

Units Affected

4390 vials

Related Recalls

6

5 from same agency

Product Description

Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

Reason for Recall

CGMP Deviations

Details

Recalling Firm
Omeza LLC
Units Affected
4390 vials
Distribution
US Nationwide
Location
Sarasota, FL

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-0288-2024
Date reported February 14, 2024
Date initiated January 19, 2024
Recalling firm Omeza LLC
Units affected 4390 vials
Distribution US Nationwide

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

Scale of Impact

4390 vials units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
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?
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS. Recalled by Omeza LLC. Units affected: 4390 vials.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on February 14, 2024. Severity: Moderate. Recall number: D-0288-2024.
Where was the recalled product distributed?
Distribution: US Nationwide.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0288-2024) 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 Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, … →

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
  • U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
  • BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
  • BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
  • U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
  • IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
  • data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

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).