In the highly regulated U.S. cosmetics market, even established brands may face situations where products must be withdrawn due to safety concerns, misbranding, or contamination. Under the Modernization of Cosmetics Regulation Act (MoCRA), the FDA now has stronger authority to oversee recalls and enforce corrective actions. This makes it critical for cosmetic companies to have a proactive recall strategy in place.
A product recall can result from several issues, including the use of adulterated ingredients, undeclared allergens, microbial contamination, or misleading claims. In such cases, the FDA expects companies to act swiftly, voluntarily recalling products to protect consumer safety and mitigate regulatory enforcement. Without a structured plan, companies risk delays, reputational damage, and costly penalties.
At XPRO America, we provide expert FDA cosmetic product recall guidance to help brands navigate this challenging process with confidence. Our services include:
- Recall Strategy Development – Creating customized voluntary recall plans to meet FDA requirements.
- Risk Assessment – Identifying whether an issue warrants market withdrawal, public notification, or corrective relabeling.
- Liaison with FDA – Acting as a trusted intermediary between your company and the FDA during recall and enforcement actions.
- Corrective Action Planning – Addressing root causes to prevent repeat compliance failures.
- Crisis Communication Support – Helping manage brand reputation during product withdrawals.
Having a recall readiness plan demonstrates a commitment to consumer safety and regulatory compliance. FDA inspectors often review recall procedures as part of facility audits, making recall preparedness a vital compliance element.
By partnering with XPRO America, cosmetic companies can ensure that if a recall situation arises, it is handled efficiently, transparently, and in full compliance with FDA expectations. Proactive planning not only protects consumers but also safeguards the company’s market position and credibility.
XPRO America offers FDA cosmetic recall guidance, recall strategy development, and FDA liaison support to help brands manage recalls quickly and compliantly