When the FDA Orders a Recall: How Cosmetic Brands Should Respond Under MoCRA

The email arrives at 9:47 AM on a Tuesday. A customer in Ohio reported a severe allergic reaction to your best-selling face serum. By 10:15 AM, three more reports come in. 

By noon, your quality assurance team confirms that a batch of preservatives from your supplier was contaminated. By 2:00 PM, you're facing a decision: voluntarily recall 15,000 units of product, or wait for the FDA to order you to do it. 

In 2023, over 320 consumer goods were recalled in the United States. For some companies, a product recall isn't just about immediate losses. It disrupts operations, damages trust, and diverts resources.

Are you prepared to manage it when it happens?

MoCRA Changed Everything: FDA Can Now Order Recalls

Before December 2022, the FDA could only request that a cosmetic company recall a product. That changed with the Modernization of Cosmetics Regulation Act (MoCRA). Under MoCRA, the FDA now has mandatory recall authority. 

Suppose the FDA determines that there is a "reasonable probability" that your product is adulterated or misbranded and that use or exposure to the product could cause serious adverse health consequences or death. In that case, the FDA can order you to recall it.

Here's what that means: Before the FDA orders a mandatory recall, it must give you a chance to voluntarily recall the product and cease distribution. If you refuse the order, you can request an informal hearing, which must be held within 10 days of the issuance of the order. The stakes are higher now. 

If the FDA orders a recall and you don't comply, you're facing not just regulatory enforcement action but potential criminal liability. Voluntary recalls are always better than mandatory recalls, they give you more control over the process and protect your reputation.

Action Step: Don't wait for the FDA to order a recall. If you discover a safety issue, initiate a voluntary recall immediately. It's faster, less damaging to your reputation, and gives you more control over the process.

Recall Classifications: Not All Recalls Are Created Equal

The FDA assigns a classification to every recall based on the degree of health hazard posed by the product. Understanding the classification is critical because it determines the urgency of your response.

Class I Recall: Reasonable probability that use will cause serious adverse health consequences or death (e.g., face cream contaminated with bacteria). Requires immediate action.

Class II Recall: May cause temporary or medically reversible adverse health consequences (e.g., lotion with failed preservative causing skin irritation). Still requires prompt action.

Class III Recall: Not likely to cause adverse health consequences (e.g., labeling error that doesn't affect safety). The classification determines the urgency of your response. 

A Class I recall requires immediate action; every hour counts. A Class III recall gives you more time, but you still need to act quickly to maintain customer trust.

Action Step: If you're facing a recall, work with the FDA to understand the classification. This will help you determine the appropriate level of response and allocate resources accordingly.

Your Legal Responsibilities in a Recall

When you initiate a recall, you have specific legal responsibilities under 21 CFR Part 7. Failing to meet these responsibilities can result in FDA enforcement action, including warning letters, product seizures, and even criminal prosecution. You must:

1. Notify your customers: Inform them about the recall and the potential health risk.

2. Notify the appropriate FDA district office: Do this immediately, not days later.

3. Submit periodic recall status reports: Keep the FDA updated on your progress.

4. Issue a public warning if necessary: If the product is already in consumers' hands, you may need to issue a press release or public notification.

5. Conduct effectiveness checks: Verify that customers are actually returning or disposing of the product.

6. Dispose of the recalled product: Whether destroyed or brought into compliance.

These aren't suggestions—they're legal requirements. In 2024, the FDA issued warning letters to multiple companies for failing to conduct adequate effectiveness checks during recalls. The cost of non-compliance is far higher than the cost of doing it right.

Action Step: Create a recall checklist based on 21 CFR Part 7. When a recall happens, you don't have time to figure out what you're supposed to do. You need a checklist that walks you through every legal requirement.

The Three Phases of Recall Crisis Management

Managing a recall isn't just about compliance; it's about crisis management. A well-managed recall can actually strengthen customer relationships. A poorly managed recall can destroy your brand. The key is to prepare for all three phases of the recall process.

Phase 1: Discovering the Problem – The faster you discover a problem, the faster you can contain it. Most recalls start with customer complaints, internal quality control flags, or supplier notifications. Investigate immediately, identify the affected batch(es), and assess the health hazard.

Phase 2: The Recall Itself – This is where most companies make mistakes. They focus on logistics (getting the product off shelves) and forget about communication (keeping customers informed). Notify your customers using clear, direct language. 

Issue a press release if necessary. Notify the FDA district office immediately. Notify your distribution partners using clear direct language. Track the recall through effectiveness checks.

Phase 3: The Aftermath and Follow-Up – The recall doesn't end when the product is off the shelves. Determine why the violation occurred. Determine what changes you need to make to keep the problem from happening again. Implement those changes. 

Communicate with customers. In 2023, companies that managed recalls strategically experienced a 27% reduction in the adverse financial consequences of crisis events compared to those that handled the process reactively.

Action Step: Create a recall response team now, before you need it. Assign roles and responsibilities. Make sure everyone knows what to do when a recall happens.

Lot Numbers and Distribution Records Are Non-Negotiable

Lot numbering is not required by law for cosmetics. But if you don't use lot numbers, you may be forced to recall an entire product line instead of a specific batch. If you discover that a batch of preservatives was contaminated, and you have lot numbers, you can identify exactly which products were made with that batch. 

You can recall 5,000 units instead of 50,000 units. Without lot numbers, you have to recall everything. Distribution records matter too. The FDA expects you to maintain distribution records for a period of time exceeding the shelf life and expected use of the product. 

In a recall, every hour counts. If you don't have distribution records, you're wasting precious time trying to figure out which products need to be recalled and where they are.

Action Step: Implement lot numbering and distribution record-keeping now. Don't wait until you need it. By then, it's too late.

Recalls Are Opportunities to Strengthen Customer Trust

This sounds counterintuitive, but it's true: A well-managed recall can actually strengthen customer relationships. 

Why? Because it demonstrates transparency, accountability, and a commitment to customer safety. 

How do you turn a recall into an opportunity? Be transparent (don't hide the problem). Be proactive (don't wait for customers to find out from the news). Be responsive (make it easy for customers to return the product and get a refund). Follow up (let customers know what you've done to prevent the problem from happening again).

In 2023, a mid-sized cosmetics company discovered that a batch of face cream was contaminated. Instead of trying to minimize the issue, they immediately issued a voluntary recall, sent personalized emails to every customer who purchased the product, and offered full refunds plus a 20% discount on their next purchase. 

The result? Customer satisfaction scores actually increased after the recall because customers appreciated the transparency and the proactive response.

Action Step: Don't treat a recall as a disaster. Treat it as an opportunity to demonstrate your commitment to customer safety and build trust.

The Bottom Line: Preparation Beats Panic

Product recalls are not a matter of if, they're a matter of when. In 2023, over 320 consumer goods were recalled in the United States. The cosmetics industry is not immune. Whether it's a contaminated ingredient, a failed preservative, or a labeling error, every cosmetic company faces the possibility of a recall. The companies that handle recalls successfully are the ones that prepare in advance. 

They have recall response teams. They have distribution records. They have a lot of numbers. They have communication plans. They have legal counsel on speed dial. They don't panic because they've already figured out what to do.

Don't wait until you're in crisis mode to figure out your recall strategy. Be proactive. Build a recall response plan now. And when the inevitable happens, you'll be ready.

The Bustos Law Group has guided hundreds of cosmetic and product companies through product recalls. We can help you develop a recall response plan, navigate the FDA's requirements, and protect your brand reputation. Contact us today for a consultation.