Maintenance Risks Fueling Cosmetic Product Recalls

The average consumer uses between six and twelve cosmetic products per day, but these products aren’t as heavily regulated by the Food and Drug Administration (FDA) as products like pharmaceuticals. As such, they may be considered “low risk” from a compliance standpoint.

However, cosmetics recalls still happen regularly, and the financial damage caused by recalls is substantial. Between November 15, 2011, and November 22, 2023, there were 334 cosmetic dermatology product recalls affecting 77 million units. Most were due to contamination and improper packaging; many of these types of recalls can be avoided with better maintenance practices.

The laws around cosmetics

While the FDA doesn’t require pre-market approval of ingredients, other than additives and colors, they still regulate cosmetics and can pursue actions against products, firms, or individuals who violate the law.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits the marketing of adulterated (violations involving product composition) or misbranded (improperly labeled or deceptively packaged) cosmetics in interstate commerce.

The FDA also can, and does, inspect cosmetic manufacturers. From a manufacturing standpoint, inspections look for:

• Improper use of restricted ingredients
• Failure to adhere to requirements for tamper-resistant packaging where required
• Labeling and packaging deficiencies
• Adequacy of the building and facilities
• Proper personnel training
• Production procedures
• Laboratory and other quality controls
• Warehousing and storage of raw materials, in-process, and finished cosmetics

Inspections can include swabs of equipment or surfaces that products come into contact with and the collection of in-process products, which are then analyzed for adulteration or misbranding.

Although Good Manufacturing Practice regulations don’t include cosmetics, the FDA has provided a Good Manufacturing Practice Guidelines Checklist. Failure to adhere to these guidelines can result in adulterated or misbranded products.

Why cosmetics get recalled

According to the Journal of the American Academy of Dermatology, the most common reasons for cosmetics recalls were:

• Microbial contamination
• Inorganic contamination
• Incorrect or undisclosed ingredients
• Labeling or packaging errors

Products may be recalled involuntarily or subject to a mandatory recall from the FDA, but with any recall, the costs escalate rapidly. Direct financial costs often reach millions of dollars. Indirect costs, including reputational damage, may be impossible to quantify but have long-lasting effects even after the reason for the recall is corrected.

But the risks and costs extend to the manufacturers, too, especially if they produce cosmetics for multiple companies.

Beyond products: The direct risks to manufacturers

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded the FDA’s authority to regulate cosmetics. Under this act, manufacturers and processors must register their facilities with the FDA and renew registrations every two years.

If the FDA determines that a cosmetic product manufactured by the facility has a reasonable probability of causing health consequences or death to humans, and believes other products manufactured by the facility may be similarly affected, the FDA has the authority to suspend the facility’s registration.

This means the manufacturer can be completely shut down and unable to distribute, sell, or deliver any cosmetic products, effectively halting operations until corrective actions are verified by the FDA.

While regulations like MoCRA raise the bar for compliance, many recalls trace back to preventable maintenance issues rather than intentional violations.

Maintenance risks in cosmetics production

Regulators rarely see recalls as single-point failures. Instead, recalls are usually the result of multiple layers of breakdowns. Equipment condition, missed or insufficient maintenance, and weak documentation can all contribute to failures.

Here are some of the most common blind spots that ultimately lead to recalls:

Equipment and facility failures

• Cross-contamination from shared equipment: Inadequate cleaning and sanitation between product runs can cause unintended ingredients in finished goods.
• HVAC and environmental control failures: Poorly maintained air handling systems can allow microbial contamination, excess humidity, or particulate ingress in clean or controlled areas.
• Water system maintenance issues: Cosmetics often rely on purified water. Biofilm buildup or skipped sanitization cycles can introduce microorganisms directly into product formulations.
• Worn seals, gaskets, and lubricants: Degraded components can shed particles, leak lubricants, or allow ingress of contaminants.

Process control and calibration gaps

• Out-of-calibration equipment: Unmaintained scales, temperature probes, or mixers can lead to incorrect formulations or unstable products.
• Inconsistent batch processing due to mechanical drift: Mixers, fillers, and pumps that aren’t regularly inspected can introduce variability batch to batch.
• Failure of automated inspection or detection systems: Poorly maintained vision systems or sensors may miss foreign matter or fill-level issues.

Preventive maintenance and planning issues

• Deferred preventive maintenance: Reactive “run-to-failure” strategies increase the risk of sudden breakdowns mid-batch, forcing rework or release decisions.
• Poor spare parts management: Using incorrect, worn, or non-approved replacement parts can alter equipment performance or violate validated conditions.
• Temporary fixes becoming permanent: Improvised repairs that bypass safeguards or design controls often surface during audits or root-cause investigations.

Packaging and container-closure failures

• Container-closure integrity failures: Poorly maintained cappers, sealers, or crimpers can lead to leaks, loss of preservative effectiveness, or post-fill contamination.
• Inconsistent torque or sealing pressure: Worn tooling or uncalibrated packaging equipment can cause under- or over-torqued closures, resulting in product exposure or consumer safety complaints.
• Foreign material introduced during packaging: Degraded belts, guides, or chutes can shed plastic, rubber, or metal fragments directly into open containers late in the process.
• Labeling and coding errors tied to equipment issues: Poorly maintained printers, vision systems, or applicators can cause missing allergen statements, incorrect ingredient lists, or unreadable lot codes.

Documentation and compliance risks

• Inadequate cleaning and maintenance SOPs: If procedures exist but aren’t detailed, current, or equipment-specific, manufacturers struggle to prove control during inspections.
• Gaps between maintenance records and actual work performed: When logs don’t match reality, it undermines data integrity and can escalate minor issues into recall-level findings.

Human and organizational factors

• Insufficient maintenance training: Technicians unfamiliar with hygienic design or cosmetic GMP expectations may unintentionally introduce contamination risks.
• Silos between maintenance, quality, and production: When maintenance issues aren’t communicated to quality teams, products may ship before problems are fully assessed.

These maintenance blind spots can lead to recalls, but using a computerized maintenance management system (CMMS) can give cosmetics manufacturers the tools to overcome these challenges, limiting risk exposure and allowing them to deliver products that are safe for consumers.

How a CMMS helps reduce recall risk in cosmetic manufacturing

Maintenance-related recalls rarely come from a single failure. They are usually the result of small gaps that accumulate over time, missed inspections, deferred work, incomplete records, or poor visibility across teams. A CMMS like eMaint helps cosmetic manufacturers close those gaps before they turn into compliance issues or recalls.

With a CMMS, preventive maintenance tasks are scheduled, tracked, and completed consistently across production, packaging, utilities, and environmental systems. Equipment inspections, calibration activities, and sanitation procedures are documented in real time, creating clear traceability when audits or investigations occur.

A CMMS also improves coordination between maintenance, quality, and operations. Issues identified on the floor can trigger corrective work orders immediately, reducing the risk of contaminated batches, labeling errors, or packaging failures reaching the market. Standardized procedures and digital checklists ensure cleanings and repairs are performed correctly every time.

Most importantly, a CMMS helps make maintenance data actionable. Trends reveal recurring failures, high-risk assets, and opportunities to intervene sooner. Instead of reacting to breakdowns or complaints, cosmetic manufacturers can move toward a more proactive maintenance strategy that supports product safety, regulatory compliance, and brand protection.

See how eMaint supports cosmetics manufacturers and reduces recall risk with a free demo.