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The Recall You Never Planned For

Why most Pharma, MedTech, and Cosmetics recalls fail — not because of quality, but because systems collapse under pressure.

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A Scenario Every Regulated Manufacturer Should Model

No manufacturer plans for a recall.

They plan to prevent one.

They invest in quality systems, audits, SOPs, and controls and assume that if a recall ever happens, the organisation will “figure it out”.

That assumption is where most recalls go wrong.

In Pharma, MedTech, and Cosmetics, recalls don’t fail because teams don’t care.
They fail because systems that work in calm conditions collapse under pressure.

This article walks through a realistic recall scenario hour by hour  and exposes where data gaps, manual processes, and disconnected systems turn a contained issue into a regulatory, financial, and reputational crisis.

The Scenario (Day 0): A Signal You Can’t Ignore

It starts quietly.
A quality manager receives an internal deviation report:

• A stability result outside trend
• A complaint referencing an adverse reaction
• A supplier notification about potential contamination

At this point, nothing is confirmed. But the clock has started. In regulated industries, time is not neutral. Every hour without clarity increases exposure.

Hour 1–4: The First Question That Changes Everything

Leadership asks a simple question:

“Which products could be affected?”
This is where systems are tested.
Not theoretically.
Not in training.
In reality.
To answer this, teams must know:

• Which batches used the material
• Which lots were produced
• Which serials (if applicable) were released
• Which products are still in inventory
• Which have already shipped If this requires:
• Multiple spreadsheets
• Cross-team calls
• Manual data stitching

You are already behind.

Hour 4–12: Data Gaps Under Pressure

As the recall scope expands, stress reveals gaps no audit ever exposed.

Common failure points
• Batch genealogy exists — but not downstream shipment linkage
• Inventory data is current — but quality status is not
• ERP shows shipments — CRM shows customers — but nothing ties them together
• Serialisation data exists — but only at manufacturing, not service

Teams start asking:
• “Is this the latest file?”
• “Who owns this data?”
• “Can we trust these numbers?”
Under pressure, uncertainty multiplies.

Regulatory Reporting Stress Begins

Day 1: Regulatory Reporting Stress Begins

Day 1: Regulatory Reporting Stress Begins

 

In Pharma and MedTech, regulators don’t wait.

Authorities such as the U.S. Food and Drug Administration expect:

  • Timely notification
  • Clear scope definition
  • Evidence-based decisions
  • Ongoing updates

But regulatory reporting requires:

  • Precise timelines
  • Defensible data
  • Consistent narratives

If systems are disconnected, reporting becomes:

  • Reactive
  • Manually assembled
  • Error-prone

Every update risks contradiction.

And contradictions destroy credibility.

Day 2–3: Forward Traceability Becomes the Bottleneck

Day 2–3: Forward Traceability Becomes the Bottleneck

 

Backward traceability is usually manageable:

“What went into this batch?”

Forward traceability is where recalls slow down:

“Where did everything go — and who is affected?”

This includes:

  • Distributors
  • Hospitals
  • Pharmacies
  • Clinics
  • End customers

In Cosmetics, this may mean retail chains and e-commerce platforms.
In MedTech, it may mean implanted devices.

If forward traceability is incomplete:

  • Recall notices are delayed
  • Over-recall becomes likely
  • Under-recall becomes dangerous

Both outcomes are costly.

Day 3–5: Financial Reality Sets In

Day 3–5: Financial Reality Sets In

By now, finance is involved.

And the questions change.

  • What inventory must be written off?
  • What revenue must be reversed?
  • What warranty or liability exposure exists?
  • What does this do to margin and cash flow?

Without real-time linkage between:

  • Batches
  • Inventory
  • Shipments
  • Customers
  • Financials

Finance works with estimates.

Estimates become disclosures.

Disclosures become risk.

Week 1: Reputation Takes Its First Hit

Week 1: Reputation Takes Its First Hit

Customers don’t judge recalls by perfection.

They judge them by:.
• Speed.
• Clarity
• Confidence

Delays signal confusion.
Confusion signals lack of control. In regulated industries:
• Hospitals escalate
• Distributors lose trust
• Partners reassess relationships

Even a well-contained recall leaves a digital footprint.
And reputational recovery is slower than operational recovery.

Why This Recall Wasn’t “Unlucky”

Most failed recalls are not caused by:
• Poor quality culture
• Bad intentions
• Lack of effort

They are caused by systems designed for compliance in calm conditions, not for execution under stress.

Audits test:
• Documentation
• Process existence

Recalls test:
• Data continuity
• Decision speed
• System resilience

These are not the same thing.

The Hidden Gap: Planning vs Preparedness

Many organisations believe they are recall-ready because:
• Procedures exist
• Templates are approved
• Mock recalls passed

But mock recalls often:
• Use ideal data
• Ignore timing pressure
• Avoid cross-system friction

True preparedness requires:
• Live data
• Real dependencies
• No manual shortcuts

If a recall requires heroics, it is not prepared.

Why Disconnected Systems Multiply Damage

In most recall failures, systems break in predictable ways:

• Manufacturing knows batches
• Quality knows deviations
• Supply chain knows shipments
• CRM knows customers
• Finance knows numbers

But no one system knows the full story. The recall becomes a coordination exercise instead of an execution exercise.
And coordination is slow under pressure.

What Recall-Ready Systems Do Differently

Recall-ready organisations don’t rely on memory or manual work.

They rely on:
• A single source of operational truth
• End-to-end traceability by design
• Real-time status visibility
• Enforced workflows

This allows teams to:
• Define scope confidently
• Act decisively
• Communicate clearly
• Report defensibly

Speed becomes a capability, not a gamble.

Why Salesforce-Native ERP Changes Recall Outcomes

In Salesforce-native ERP architectures:
• Manufacturing, inventory, quality,
CRM, and finance share one data model • Batch, lot, serial, and shipment data are linked natively
• Audit trails are automatic
• Reporting is consistent across functions

This reduces recall execution from:
“Let’s figure this out” to:
“Here is the impact — now let’s act” In regulated environments, that difference is everything.

The Real Cost of an Unplanned Recall

The biggest cost is not:
• Scrap
• Write-offs
• Penalties It is:
• Loss of trust
• Regulatory scrutiny
• Internal fatigue
• Long-term brand damage

Recalls don’t end when products are returned.
They end when confidence is restored.

You Don’t Rise to the Occasion — You Fall to the System

In a recall, people do their best.
Systems decide the outcome. If your systems:
• Fragment data
• Delay truth
• Depend on manual effort

They will fail you at the worst possible moment.

The recall you never planned for is not hypothetical.

It is a scenario every regulated
manufacturer should model — honestly, under pressure, without assumptions.

Because when it happens, there is no time to redesign systems. Only to reveal them.

Axolt delivers Salesforce-native ERP solutions for Pharma, MedTech, and Cosmetics manufacturers that require real-world recall readiness.

Axolt helps organisations:
• Build true end-to-end traceability
• Eliminate recall data gaps
• Accelerate regulatory reporting
• Reduce financial and reputational exposure

All natively on Salesforce.

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