top of page

Recalls Will Cost You—But Not As Much If You Call Your Lawyer First

Updated: Jun 18


Sign reading "FDA RECALL" in bold black letters on a red-bordered white background. Set against a textured, smoky gray backdrop.

The legal blind spots that turn a manageable recall into a costly crisis—and how I help my clients avoid them.


If you’re in the food, supplement, or cosmetics industry, you probably already know: product recalls happen. Even with airtight SOPs, strong QA processes, and a responsible team, no business is immune.


But here’s what many founders and quality leads don’t realize until it’s too late:

Recalls aren’t just operational issues. They’re legal events. And if legal isn’t involved from the moment you suspect a problem, the cost of the recall, financially and reputationally, can spiral quickly.

 


What Recalls Really Cost You

When a recall hits, most teams focus on the obvious:

  • Pulling product

  • Managing logistics

  • Communicating with retailers or customers

But beneath the surface, there are deeper, often unbudgeted risks:

  • Regulatory penalties and investigations

  • Civil lawsuits

  • Breach of contract claims from suppliers or distributors

  • Reputational damage that lingers long after the recall is resolved

These are the kinds of risks that I help my clients navigate every single day.

 


What I Do for Clients When a Recall Happens

When my clients reach out about a potential recall, here’s how I step in to protect their business from every angle:

1. I Preserve Privilege and Minimize Exposure

Before anything is said or documented, I help structure the internal response so that sensitive communications remain privileged. This is critical to protecting the company if litigation follows.

2. I Guide Regulatory Communication

I don’t let my clients go into conversations with the FDA unprepared. I help draft or review all reports and correspondence, advise on what to disclose (and how), and ensure your submissions are accurate, compliant, and strategically sound.

3. I Control the External Narrative

Every recall requires external communication—customer notices, press releases, distributor updates. I make sure every statement serves two purposes: regulatory compliance and brand protection. One wrong phrase can trigger unnecessary scrutiny or lawsuits.

4. I Align Your Team for Rapid Response

Recalls are cross-functional events. I help clients coordinate efforts across quality, ops, legal, and comms so nothing gets missed and everyone is working from the same playbook.

5. I Help You Build a Better Plan (After the Storm Passes)

Once the immediate crisis is over, I guide clients through post-recall strategy—root cause documentation, CAPAs, and SOP updates—to prevent the next issue and strengthen their compliance posture.

 


The Most Costly Recalls? The Ones Where Legal Came In Late

If legal isn’t involved until after the FDA is on-site or the press is already involved, the damage is harder—and more expensive—to control.

Most of the worst-case scenarios I’ve seen weren’t due to intentional negligence. They were due to good teams trying to handle recalls without legal strategy, hoping to fix the issue internally first.

But once public statements are made or regulatory deadlines are missed, those “fixes” become liabilities.

 


Proactive Legal Strategy Saves More Than Just Money

When I work with clients before a recall, we’re not just reacting—we’re planning. That means:

  • A ready-to-activate recall protocol

  • Clear FDA communication workflows

  • Templates and review processes for customer-facing materials

  • Contract review for risk exposure

This level of preparation not only protects your business, it builds trust with regulators and stakeholders when it matters most.

 


If You Don’t Have a Legal Recall Strategy, You Don’t Have a Recall Strategy

Recalls are high-risk, high-stakes events. You don’t need to handle them alone, and you shouldn’t.


If your business handles FDA-regulated products and you don’t have a recall response plan that includes legal strategy, let’s fix that. I help clients prepare, respond, and recover—without losing control.

 
 
 

Comments


bottom of page