Recalls

PRODUCT RECALLS

Product Recalls are very urgent and sensitive matters that can have a significant impact on your brand, customers, and future business. Recalls can have significant legal and regulatory costs and consequences to brand owners. Ingredient or Food Recalls must be handled skillfully and appropriately to reduce the risk of possible injury or additional damages to consumers. REJIMUS provides full Recall Program design, Recall Management and Recall Training (including conducting Mock Recalls) to respond adequately to either Mandatory Recalls or Voluntary Recalls. We have the team, protocols and best practices as well as project management systems in place that effectively and efficiently oversee Product Recalls through to close out, before further regulatory actions and/or legal actions are taken against your brand.

A Recall is an action taken to address a problem with an ingredient or finished product that violates the law as enforced by the FDA, FTC, USDA or other governing regulatory agency. Product recalls may occur for any number of reasons including, but not limited to defective packaging, adulterated materials, contaminated products, noncompliant manufacturing practices, incomplete or inaccurate testing results, inappropriate test methods, improper storage of materials or products, or label claims that are not permitted or substantiated, etc.

A product recall depends on several factors that require urgent, appropriate and compliant investigations in order to be properly close out. Language in manufacturing service agreements may or may not identify the roles and responsibilities of handling recalls. The ultimate responsibility for recall management is that of the Brand Owner. Recall Procedures and a well written Recall Plan for all the products or ingredients alone is insufficient. Adequately designed recall programs must include specific documentation, protocols and the correct evaluation of the following:

  • Inspecting the materials or products for problems
  • Repairing the materials or products
  • Re-labeling the materials or products
  • Destroying the materials and products
  • Notifying consumers of a problem and tracking/report of responses
  • Monitoring the product returns for a set period of time

To understand more about ingredient recalls or finished product recalls for Food or Beverage products, Dietary Supplements, Cosmetics, Animal Feed products, or Homeopathics, please contact us today for an open conversation about your situation and we can quickly assess the situation in order to define next steps to properly handling or preparing for a recall and then ensure the recall is properly closed out.

Current List of FDA-Regulated Recalled Products

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Recall Summary Form
Is a recall required? *
Are recall procedures in place? *
Was a mock recall conducted? *
Is there a written recall plan? *