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The Wild Waters of an FDA Recall

Recalls are critical for ensuring public safety when products pose health risks but for businesses, this also means reacting quickly to contain the bleeding, limit supply chain disruption and avoid business and reputation damage while simultaneously working alongside the FDA, which plays a pivotal role in managing and helping effectuate recalls – a juggle of multiple interests to say the least!

Effective and timely execution of a recall involves several key steps in a short period of time, from identification of the issue to determining recall scope, recall strategy, and recall effectiveness, resulting in eventually, a successful recall termination. Whew!

FDA’s recent recall of bottled water, involving potential bacterial contamination and manganese after the Company was notified of a quality issue with complaints of discoloration in certain products, helps illustrate best practices. To assist with making key recall decisions timely and to avoid a fizzy fiasco, we will take a look here at the practical steps for executing a recall, and strategies for ensuring recall preparedness.

Regulatory Authority and Types of Recalls

Deriving its authority from the Federal Food, Drug and Cosmetic Act (FDCA), the Agency has the authority to oversee recalls which include three main types:

  • Voluntary recalls: Initiated by the company
  • FDA-Requested Recalls: Initiated by the company at the request of the FDA
  • FDA-Mandated Recalls: Legally required and enforced by the FDA; typically for foods posing serious health risks, medical devices and biological products

Please also note that as we have reported previously, FDA now has authority to order a mandatory recall for cosmetics and personal care products if the Agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded, and the use of or exposure to such a cosmetic will cause serious adverse health consequences or death. The nature of this mandatory recall authority is similar to FDA’s authorities across other industries, e.g. for foods, supplements, medical devices, and OTC drugs.

Now, let’s get right to the recall rapids!

Practical Steps for Executing an FDA Recall

      1. Establish a Recall Team:

  • Recall Coordinator: Designate a recall coordinator responsible for overseeing the entire recall process.
  • Legal Counsel: Engage legal counsel to ensure compliance with regulatory requirements and manage potential legal risks.
  • Communication Team: Prepare a team to handle internal and external communications.

    2. Develop a Recall Plan:

  • Identification and Evaluation: Establish procedures for identifying potentially hazardous products and evaluating the scope of the issue. This is perhaps one of the most critical procedures we recommend businesses develop to identify the recall scope, recall depth and strategy to clearly define and limit the issue.
  • Notification Procedures: Define clear procedures for notifying the FDA, distributors, retailers, and consumers.
  • Recall Strategy: Develop strategies for effectively removing the product from the market, including logistics for returns and disposal.

    3. Communication:

  • Internal Communication: Ensure that all employees are informed about the recall and their roles in executing it.
  • External Communication: Use clear, concise, and transparent messaging to inform stakeholders, including the public, about the recall and its implications.

    4. Notification to the FDA:

  • Report Initiation: Notify the FDA promptly about the recall, providing detailed information about the affected products, the reason for the recall, and the steps being taken.
  • Recall Effectiveness Reports: Submit regular reports to the FDA on the progress of the recall, including the number of products recovered and the effectiveness of the recall strategy.

    5. Execution of the Recall:

  • Product Retrieval: Implement the logistics plan for retrieving the affected products from the market.
  • Correction or Disposal: Ensure that the recalled products are either corrected (if possible) or disposed of properly to prevent further risk.

    6. Post-Recall Actions:

  • Root Cause Analysis: Conduct a thorough investigation to determine the root cause of the issue that led to the recall.
  • Corrective Actions: Implement corrective actions to prevent recurrence, including process improvements and additional training for employees.
  • Review and Revise Recall Plan: Assess the effectiveness of the recall plan and make necessary revisions based on the lessons learned.

Strategies for Recall Preparedness

        1. Regular Audits and Testing:

  • Quality Control Audits: Conduct regular audits of manufacturing processes, supply chains, and quality control systems to identify potential risks.
  • Product Testing: Implement rigorous testing protocols to ensure product safety and compliance with FDA standards.

    2. Training and Education:

  • Employee Training: Provide regular training for employees on recall procedures, FDA regulations, and quality control measures.
  • Scenario Planning: Conduct mock recalls and scenario planning exercises to test the recall plan and ensure readiness.

    3. Documentation and Record-Keeping:

  • Detailed Records: Maintain detailed records of all production batches, testing results, and quality control measures.
  • Recall Documentation: Keep comprehensive records of all recall-related activities, including notifications, retrieval efforts, and corrective actions.

    4. Legal and Regulatory Compliance:

  • Stay Informed: Regularly review updates to FDA regulations and guidelines.
  • Legal Counsel: Consult with legal counsel to ensure that the recall plan complies with all legal and regulatory requirements.

    5. Communication Strategy:

  • Crisis Communication Plan: Develop a crisis communication plan that includes templates for press releases, FAQs, and stakeholder communication. This is also one of the most critical proactive plans we recommend businesses develop. When the stakes are high, having pre-drafted customer notices, press releases and communications can significantly ease the regulatory burden (and stress!), and help businesses get back to doing business more quickly.
  • Transparency: Commit to transparency and honesty in all communications related to the recall.

Recall Conclusion

Effectively executing an FDA recall requires meticulous planning, robust quality control measures, and a proactive approach to regulatory compliance. By establishing a comprehensive recall plan, regularly training employees, and maintaining open communication with the FDA and the public, businesses can navigate the complexities of a recall and minimize its impact. Preparedness is key to protecting consumer safety, maintaining regulatory compliance, and safeguarding the company’s reputation.

For more information on FDA recalls including developing FDA recall plans and procedures, recall strategy and effectuating an FDA recall, please contact us at

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