Hand soap bottle with red recall stamp, representing Walmart US hand soap recall over Burkholderia cepacia contamination.

Life-Threatening Bacteria Triggers US Hand Soap Recall — What Quality Pros Must Do

Date of Recall: August 8, 2025
 Manufacturer: DermaRite Industries, LLC (New Jersey, USA)
 Affected Regions: United States & Puerto Rico

Summary

DermaRite Industries has voluntarily recalled multiple lots of its hand soap, cleanser, and antiseptic products after detecting contamination with Burkholderia cepacia (Bcc) — a bacteria capable of causing serious or life-threatening infections in vulnerable individuals.

Affected Products

  • DermaKleen Antiseptic Lotion Soap with Vitamin E (1,000 mL & 800 mL)
  • KleenFoam Antibacterial Foam Soap with Aloe Vera (1,000 mL)
  • DermaSarra External Analgesic (7.5 oz)
  • PeriGiene Antiseptic Cleanser (7.5 oz)

 

Expiration Dates: July 2025 – February 2027
 Distribution: U.S. & Puerto Rico
 A full list of affected lot numbers is available on the FDA recall notice.

Why This Matters

Burkholderia cepacia is a waterborne, opportunistic pathogen that can survive in moist environments and resist many common disinfectants.

  • In healthy individuals: May cause localized skin infections.
  • In immunocompromised individuals: Can spread to the bloodstream, leading to life-threatening sepsis.
  • High-risk groups: Those with chronic lung diseases (e.g., cystic fibrosis) or weakened immune systems.

Symptoms to Watch For

  • Fever, fatigue
  • Localized redness, swelling, or irritation at the site of contact
  • Respiratory distress (in susceptible individuals)

Because B. cepacia infections can be asymptomatic initially and may resist standard antibiotics, prompt medical evaluation is advised if exposure is suspected.

What to Do if You Have These Products

  • Stop using immediately.
  • Check lot numbers against the official FDA recall notice.
  • Dispose of affected products according to local waste guidelines — do not pour into sinks or drains.
  • Contact your healthcare provider if you suspect exposure, especially if you are immunocompromised.
  • Some of the affected products may have been available through major retailers, including Walmart, according to consumer reports.

Reference

📌 View the FDA Recall Announcement

Gap Analysis & Immediate Actions for Quality Teams

When news like this drops, quality leaders should not just forward it to colleagues — they should use it as a trigger for a rapid internal health check. Here’s a recall-inspired gap analysis checklist you could send to your teams right away:

1️⃣ Product & Risk Scope Review

  • Identify all water-based, non-sterile, or topical products in your portfolio.
  • Review contamination risk assessments — especially for opportunistic pathogens like Burkholderia cepacia.
  • Confirm whether products are used by immunocompromised populations or in healthcare environments.

2️⃣ Environmental Monitoring & Water Systems

  • Re-check Purified Water (PW) / Water for Injection (WFI) microbiological specifications — ensure they include opportunistic pathogens, not just total microbial count.
  • Audit cleaning & sanitization records for filling lines, mixing tanks, and holding vessels.
  • Verify biofilm control strategies — B. cepacia thrives in biofilms inside water systems, pipes, and hoses.

3️⃣ Supplier & Raw Material Controls

  • Review supplier qualification for high-risk inputs (e.g., surfactants, emulsifiers, plant extracts, water-based excipients).
  • Ensure microbial specifications for incoming materials include environmental opportunistic pathogens.

4️⃣ Change Control & Trending

  • Verify change control history for any recent equipment, supplier, or process modifications affecting water systems or sanitation.
  • Review microbiological trending reports for early warning signs — small spikes before the breach.

5️⃣ Contingency Readiness

  • Test your recall procedure — can you trace all distributed product within hours?
  • Ensure cross-functional recall team readiness (quality, supply chain, regulatory, communications).

Can This Bacteria Contaminate Pharma, Food, Med Device, API, Biotech, or Vaccines?

Yes — Burkholderia cepacia is multi-sector relevant.

Burkholderia cepacia is environmental, waterborne, and opportunistic, which means it can contaminate products in multiple sectors:

Sector

Potential Risk Points
Pharma Aqueous non-sterile products, inhalation solutions, nasal sprays, oral suspensions, topical creams
API Manufacturing Water-based steps in synthesis or purification, wet milling, liquid intermediates
Medical Devices Pre-moistened wipes, gels, lubricants, wound care solutions, any device with residual moisture
Biotech Media prep, buffer solutions, cell culture reagents
Vaccines Contamination of non-sterile bulk solutions during manufacturing (rare due to strict asepsis)
Food Moist environments in processing plants, especially water-based flavorings or syrups (less common)

What Quality & Microbiology Professionals Should Do Immediately

  • Expand Your Spec List → Add B. cepacia to in-process and finished product microbiological specs where relevant.
  • Audit Your Water System → Check system design, dead legs, sanitization frequency, and microbial testing points.
  • Review Environmental Monitoring Program → Ensure EM covers high-moisture risk zones and uses targeted microbial identification, not just counts.
  • Check Preservative Effectiveness → Conduct preservative challenge testing, especially for long shelf-life products.
  • Strengthen Supplier Oversight → Require proof of microbial control in supplier processes and test independently upon receipt.
  • Train Staff → Refresh teams on contamination prevention, biofilm risks, and aseptic/clean handling in non-sterile production.
Pharmaceutical worker hesitating to follow SOP in GMP manufacturing environment

The Psychology of Not Following SOPs — and How to Fix It

The audit room was tense and with pile up of SOPs. A stack of batch records sat between the QA lead and the auditor, and everyone knew there was a problem in one of them. Not a catastrophic failure — but a small deviation in SOP that had never been reported.

If you’ve been in GMP long enough, you’ve seen this story before. Someone skips a step of SOP, follows “how we usually do it” instead of what’s written in the SOP, or makes a “temporary” change without approval. Later, during an inspection, that “small thing” becomes the opening line of a 483 observation or an inspection finding.

Why does this happen in environments where compliance is drilled into us? And more importantly, how do we fix it — without burning out our teams or making SOPs into binders nobody reads?

In this article, we’ll explore the psychology of why SOPs aren’t always followed, the human factors behind it, and practical ways to rebuild SOP ownership across your teams.

Why SOP Exist — And Why People Still Skip Steps

We all know the textbook reason: SOPs ensure consistency, compliance, and safety. But in practice? Many employees view them as bureaucratic paperwork that slows them down.

I once walked into a cleanroom where a new operator had been trained on the correct gowning procedure.
Yet, during the shift, they skipped the second pair of gloves.
Why? “It’s faster this way — and everyone does it like this when no one’s watching.”

This isn’t about laziness.
It’s about perception.
If the operator’s daily reality tells them speed is valued over strict compliance, they’ll unconsciously align their behavior with what the culture rewards.

Here are the 10 Reasons Why People Don’t Own SOPs.You can also explore my in-depth LinkedIn newsletter on this topic for more real-world GMP insights.

Top 10 reasons why employees in GMP environments don’t take ownership of SOPs.
Ten (10) key psychological and operational barriers to SOP ownership.

The Early Warning Signs You’re Slipping Into SOPs Non-Compliance

Non-compliance doesn’t start with a critical deviation.
It begins with small behaviors that quietly erode GMP discipline.

You might notice:

  • Operators writing from memory instead of following instructions step-by-step.

  • Minor undocumented changes to process timing.

  • Batch record entries made “later” instead of in real time.

  • Workarounds for inconvenient controls.

Each one seems harmless until you zoom out.
What’s dangerous is not the act itself, but the normalization of deviation.

The worst part? By the time these habits surface in an audit, the behaviors are already deeply embedded in the culture.

Here are the – 11 Early Warning Signs in GMP Environments.

Eleven early warning signs of SOP non-compliance in pharmaceutical manufacturing.
Early indicators that SOP compliance is slipping — before major deviations occur.

Read the full FDA 21 CFR Part 211 regulation here.

The Grey Zones That Invite SOP Shortcuts

Every facility has them — the “grey zones” where procedures aren’t crystal clear, or where the wording leaves room for interpretation.
These gaps in documentation create a breeding ground for “personal versions” of the SOP.

Example:
An SOP says, “Visually inspect the equipment for cleanliness before use.”
No one defines what “cleanliness” means, or documents the inspection step with photos or checklists.
So, each operator decides what’s “clean enough.”

From a QA perspective, this is a nightmare.
From an operator’s perspective, it’s just making a judgment call in the moment.

Here are the – 10 Grey Zones in GMP Documentation

Ten common grey areas in GMP documentation that lead to SOP shortcuts.
Where SOP language leaves room for risky interpretation.

Read the PIC/S Guide to GMP for detailed global quality requirements.

The SOP Compliance Struggles Nobody Talks About

In most GMP shops, there’s a silent tension:
Production feels pressured to meet output targets.
QA feels pressured to ensure compliance no matter the schedule.

This tension shows up as:

  • Frustration when QA rejects work.

  • Resistance to procedural changes.

  • Operators feeling QA “slows everything down.”

The truth is, SOP ownership is low when teams feel SOPs are designed for auditors instead of for the people doing the work.

Twelve operational and cultural challenges that weaken GMP compliance.
The most common struggles teams face in sustaining GMP compliance.

Read the WHO GMP Guidelines to understand internationally recognized GMP standards.

Data Integrity — Where Small Slips in SOP Become Major Findings

Data integrity issues are rarely the result of malicious intent.
Most often, they start with small, pressured decisions:
“I’ll fill this in later.”
“This test result is obviously okay — I don’t need to double-check.”

Over time, these shortcuts form habits, and habits leave trails in your audit logs.

Whether it’s missing signatures, out-of-order entries, or undocumented corrections — each one can trigger a regulatory citation.

Here are : Top 13 Data Integrity Issues

Thirteen most common data integrity problems in GMP-regulated industries.
The most frequent audit findings related to data integrity.

Read the MHRA GxP Data Integrity Guidance for UK regulatory expectations.

How to Increase SOP Ownership Across Your Teams

Improving SOP compliance isn’t just about retraining.
It’s about changing how people perceive and value the SOP itself.

Some practical approaches:

  • Involve operators in SOP drafting.

  • Use visual SOPs where possible.

  • Align KPIs so compliance is rewarded alongside productivity.

  • Encourage feedback loops for SOP improvements.

  • Make SOPs easy to navigate on the shop floor.

Here are: Top 8 Ways to Increase SOP Ownership

Eight practical strategies to improve SOP ownership across GMP teams.
Boost engagement and compliance with these proven SOP ownership tactics.

Read the ICH Q10 Pharmaceutical Quality System guideline for a structured approach to GMP compliance.

Reflective Takeaway

GMP isn’t just about doing things right.
It’s about building systems where people want to do things right — because they see the value, not just the rule.

When SOP ownership is high, audits stop being fear-driven events.
They become proof points of a healthy quality culture.

FAQs – SOP Compliance

  1. Why do people often skip following SOPs in GMP environments?
    Many employees face time pressure, unclear instructions, or lack motivation, causing them to bypass SOP steps despite knowing their importance.

  2. Is skipping SOPs always due to human error?
    Not necessarily. Often, it reflects systemic issues like poorly designed procedures, inadequate training, or a culture that discourages reporting deviations.

  3. How can quality leaders reduce SOP non-compliance?
    Leaders can model good behavior, foster open communication, and involve teams in creating realistic, user-friendly SOPs.

  4. What role does workplace culture play in SOP adherence?
    A positive culture where employees feel safe to speak up encourages consistent SOP compliance and reduces hidden deviations.

  5. How does burnout impact SOP compliance?
    Burnout reduces focus and motivation, making employees more prone to take shortcuts or overlook critical steps.

  6. Can behavioral CAPA improve SOP adherence?
    Yes, by addressing root causes beyond retraining, such as mindset, environment, and leadership support, behavioral CAPA leads to sustainable improvements.

  7. What practical steps can teams take to make SOPs more followable?
    Using visual aids, simplifying language, piloting SOPs with operators, and soliciting regular feedback helps make SOPs easier to follow.

  8. How does audit readiness relate to SOP compliance?
    Consistent SOP adherence minimizes deviations and findings during audits, ensuring smoother inspections and regulatory trust.

Want more insights like this?

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