What doesn’t go hand-in-hand?

Product recalls and a good brand reputation.

When a product recall occurs due to a labeling error, it’s no longer just about correcting a typo or fixing a design detail. It’s about scrambling to trace back to its root cause before things get out of hand.

In a highly regulated industry, the inability to respond quickly without proof can mean losing consumer trust and revenue in millions and significant regulatory penalties.

Did you know that a report from the National Center for Food Safety & Toxicology estimates that product recalls cost the U.S. economy about $100 billion annually?

So, how do you keep your brand or product off that list?  

This blog explores how your packaging and regulatory teams can proactively build a review process that’s not only efficient and collaborative but also audit-ready from day one.

What happens when there’s a recall?

The moment a recall hits, brands go into crisis mode. A chain of questions begins:

• Was the error in the artwork or the content?

• Who approved this version?

• When was this change made and by whom?

• Was it caught in any previous rounds of review?

Answering these questions shouldn’t take hours of email digging or Slack thread combing. Yet, that’s often what it looks like. Teams search shared drives, scroll through PDFs, or rely on anecdotal memory. In many cases, there’s no structured version history or approval log to fall back on.  

This lack of clarity doesn't just delay resolution but could create tension with regulators and severely affect your brand's credibility.  

We analyzed 800+ FDA product recalls - Here's what you must know.

Why recalls are a risky business

Well, earning a spot in the news column for a product recall won’t look fun, will it?  

A careless error can do far more than inconvenience to your teams and company. It can erode trust across your entire value chain and customers.  

These are the costs that follow a product recall:

• Financial costs: Product recalls are expensive. They often involve product retrieval, disposal, reprinting, restocking, testing to find out the cause, and legal fees. Depending on the size of the distribution, these costs can run to a whopping six figures.

• Time drain: From investigating the cause to coordinating corrective actions, recalls consume time across almost every team and department.  

• Brand reputation: The most intangible, yet most lasting damage of all. Your consumers expect accuracy and quality, especially in categories like food, pharma, and personal care. A single error can lead to years of trust rebuilding.

• Regulatory exposure: In industries with tight regulations, a recall could trigger audits, fines, and increased scrutiny in future product launches.

What does "recall-ready" actually mean?

Being recall-ready means your organization has the resources to respond immediately, with complete clarity, to any sudden audit or recall request. It means your packaging review process is traceable, documented, and compliant from start to finish.

Here’s what being recall-ready looks like:  

1. Documented approvals: Every change to your artwork or label is approved by the right people and clearly documented. You should be able to see who signed off and when.

2. Version control: Each version of a file is stored, dated, and identifiable. This prevents confusion and ensures the right version goes to print every time.

3. Time-stamped audit trails: Every edit, comment, and decision is time-stamped and logged in a central system, creating a transparent and traceable history of changes.

4. E-signatures and compliance evidence: Electronic signatures add a layer of security and legality to approvals, allowing your teams to prove due diligence and meet regulatory requirements without delay.

What’s wrong with most packaging workflows?

Last year, we analyzed the state of reviews among packaging teams, and surprisingly, we found that 60.3% of respondents still depend on shared documents and physical samples to review packaging assets. I mean, is that even practically possible in 2025? 👀

But what we learnt from the report is that many packaging teams to date rely on outdated, disjointed workflows that are highly vulnerable to errors. The most common errors that can backstab your workflow later include:

1. Email-based feedback: Feedback often comes in through multiple email threads, making it nearly impossible to maintain a single source of truth. Important context gets lost in the shuffle and how is one supposed to move forward with it?

2. Lack of version control: Files are saved with ambiguous names like "Label_v3_FINAL_FINAL.pdf," making it unclear which version is truly final. Mistakes here can lead to incorrect files being sent to print.

3. No centralized audit trail: When approvals are given informally over calls or chats, there’s no paper trail to fall back on during a crisis.

4. Human checklists: Without automation, compliance tasks are often tracked manually, increasing the risk of human error and oversight.

5. Delayed reviews: Without clear ownership and deadlines, reviews drag on, and key steps are missed, especially when multiple stakeholders are involved and there’s yet another regulatory deadline to meet.

“The question is not whether technology can revolutionize packaging reviews, but rather, how quickly the industry will start using it to go beyond traditional workflows to embrace context-aware, AI-driven processes to get on the shelves faster.”

- Ankit Tomar

Senior Director, Esko

How to build a safer, smarter review process with Artwork Flow

The most resilient packaging review processes share a few key traits: they're centralized, structured, traceable, and built for compliance from the ground up. But getting there doesn’t have to mean overcomplicating your team’s day-to-day work.

What one needs is an all-in-one artwork management system that automates packaging workflows, ensures regulatory compliance, shortens turnaround times, and improves team communication.

Enter Artwork Flow.  

1. Centralize feedback, files, and approvals

When files and feedback live across inboxes, drives, PDFs, and Slack, the risk of oversight is unavoidable. Instead, bring everything together in one platform where:

• Teams across design, packaging, QA, compliance, etc see the same file in real time.

• Comments and markups are contextual and stored.

• Review cycles are trackable and transparent.

This eliminates siloed inputs and ensures everyone’s on the same page from draft to approval.

2. Set up role-based workflows

A compliant review process depends on approvals happening in the right order i.e. packaging design first, legal next, regulatory last, for example. Ad-hoc workflows with loose ends make it easy to miss critical steps or feedback. Here’s how Artwork Flow helps you out here:

• Define role-based approvals and control reviewer visibility.

• Automate workflow sequencing based on your internal process.

• Ensure nothing moves forward without required sign offs.

A proper structure like this ensures accountability and removes ambiguity over who approves what, and when.

3. Clarify versions without confusion

Version errors are one of the main causes that lead to a product recall. The key to good version control is visibility. With Artwork Flow,

• Compare artwork versions including changes in the images, regulatory text, and font size side-by-side.

• Find prior uploads instantly and review comment threads.

• Make file history visible to all stakeholders.

Now, you can avoid the common pitfall of approving outdated or mislabeled files—like that one version where the dosage reads 20 teaspoons of cough syrup twice a day instead of 2. Let’s prevent that kind of jump scare from reaching your consumer or the regulator’s desk.

4. Log every approval with full traceability

When a recall hits, what matters most is being able to answer: Who approved this? When? And what did they see? Approvals buried in emails or vague messages won’t stand up to regulatory scrutiny.

Artwork Flow solves this with:

• Time-stamped audit logs of every user action.

• Built-in e-signature support for compliant approvals.

• Storing a transparent record of comments, rejections, and status changes.

This creates an airtight, defensible trail of every decision which helps your team prepare for unexpected audits, inquiries, or internal reviews.

5. Stay ahead of recalls with artwork compliance

Our smart compliance tool flags regulatory risks before they become liabilities. It is specifically built for your packaging, QA, NPD, and regulatory teams and helps you:

• Detect compliance violations such as incorrect claims, missing mandatory disclosures, or font size issues.

• Review packaging files with customizable rules for every labeling element including allergen and ingredient information, FDA nutrition table format, recycling logos, and more.  

• Verify barcodes and QR codes on labels preventing from sharing wrong information.

For teams managing high volumes of regulated packaging, smart compliance is a proactive control, making your entire process recall-resistant by packaging and labeling design.

Wrapping up

The bottom line? Building a recall-ready packaging review process is all about bringing clarity, control, and confidence to your operations.

With a smart label compliance tool like Artwork Flow, you get a system that supports structure, visibility, and compliance from the very first step, so you’re never left scrambling when something goes wrong.

To learn more, schedule a call with our team.

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