Key obligations

• Maintain a written recall plan with roles, decision criteria, and notification scripts.
• Assemble an incident response team with clear escalation paths.
• Track distribution to lot level for every sales channel.
• Run mock recalls and document lessons learned.

Evidence regulators expect to see

• Recall playbook, contact rosters, and communication templates.
• Distribution exports that connect lots to customers or retail locations.
• Incident logs showing prior withdrawals or drills and the corrective actions taken.
• Supplier and 3PL agreements that describe recall responsibilities.

Intake sections that populate this section

• Recall Preparedness
• Records Access
• Suppliers & Testing

Relevant SOP templates

• Recall Management SOP

Risk of non-compliance

• FDA can order a compulsory recall and publish consumer alerts.
• Retailers may impose chargebacks or remove the brand from planograms.
• Civil liability increases if the recall is slow or incomplete.

Further reading

• 21 U.S.C. § 364g – Mandatory recall authority
• FDA Recalls, Market Withdrawals & Safety Alerts