Fda recall letter template 2025

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  1. Click ‘Get Form’ to open the FDA recall letter template in our editor.
  2. Begin by entering your company letterhead at the top of the document. This includes your company name, address, and contact information.
  3. In the 'URGENT' section, specify the type of product being recalled (e.g., FOOD, DRUG) and insert the date of the letter.
  4. Fill in the contact name or department responsible for handling inquiries regarding the recall.
  5. Provide detailed information about the recalled product, including its name, brand, description, UPC codes, and lot numbers.
  6. Clearly state the reason for the recall and any potential health hazards associated with using or consuming the product.
  7. Include shipping dates and quantities if applicable, to help recipients identify affected products in their inventory.
  8. Add instructions for customers on how to handle the recalled product and encourage them to notify their own customers if they have distributed it further.
  9. Finish by signing off with your name, title, and any enclosures that may assist in notifying customers.

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It outlines the affected product details, reasons for the recall, corrective actions, and instructions for recipients. Company and Product Information. Reason for Recall. Potential Risks. Actions Required. Instructions for Product Return/Disposal. Affected Entities. Compensation or Replacements. Additional Information.
Manufacturers will notify registered owners by first class mail within 60 days of notifying NHTSA of a recall decision.
This recall has been initiated due to [describe problem and how it was discovered]. [Use/Consumption] of this product may [describe any potential health hazard]. This product was shipped between [range of distribution dates] or This product was shipped to you on [date].
FDA can use its mandatory recall authority under section 423 when it determines there is a reasonable probability that the food is adulterated under section 402 or misbranded under section 403(w) of the FDC Act and that the use of or exposure to such food will cause serious adverse health consequences or death to