The short answer
If a food facility registered with FDA finds that a food it has already shipped has a reasonable probability of causing serious adverse health consequences or death — for example Salmonella in a ready-to-eat product or an undeclared major allergen — it must report it to FDA’s Reportable Food Registry (RFR) within 24 hours, through the Safety Reporting Portal.
A recall usually follows. In the U.S. most food recalls are voluntary, run by the company and overseen by FDA — but FDA can order a recall if a company refuses.
When must you report?
| Situation | Report to RFR? |
|---|---|
| Shipped product tests positive for Listeria monocytogenes or Salmonella (ready-to-eat) | Yes, within 24 hours |
| Retail packs found with an undeclared major allergen | Yes, within 24 hours |
| Problem started at your plant, was caught before any product left your control, and was corrected or destroyed | No — this exemption applies only when all three are true |
| Minor quality issue with no serious health risk | No |
| Infant formula or dietary supplements | Not through the RFR — these have their own reporting rules |
What happens after a report
- 1File the reportThrough the Safety Reporting Portal, as soon as practicable and no later than 24 hours after you determine the food is reportable. You receive an ICSR number.
- 2Notify the supply chain if FDA requires itAfter consulting FDA, you may have to notify your immediate suppliers and customers and give them the report number — they may then need to report too.
- 3Recall the productWork with your U.S. importer and FDA on the recall strategy: depth (wholesale, retail, consumer), press release if needed, and effectiveness checks.
- 4Find the root causeInvestigate, correct and document. Expect FDA to look at the facility’s next shipments more closely; repeat problems can lead to an import alert.
The foreign supplier’s role
- Your U.S. importer must review complaints and take corrective action under its FSVP, so expect it to ask for your investigation and corrective actions.
- Keep lot codes on every case and pack, and a list of which lots went to which customer — this decides how big the recall is.
- Have a written recall procedure with contacts (importer, U.S. Agent, FDA district) and practice it with a mock recall.
Example: a cookie maker in the Netherlands
A Dutch cookie maker learns from its U.S. importer that a batch of hazelnut cookies was packed in wrappers for its plain butter cookie — so the hazelnut (a tree nut) is undeclared. The packs are already in U.S. stores. An RFR report is filed within 24 hours, both companies agree a voluntary recall to consumer level with FDA, and the Dutch plant adds a wrapper-verification check at line changeover. Because the lot codes are on every pack, only one production day is recalled.
FSVP program development from $400 per supplier. FSVP Qualified Individual annual retainer $200. FSVP compliance audit and gap assessment $250.
Frequently asked questions
How fast must a reportable food be reported?
As soon as practicable and no later than 24 hours after the responsible party determines the food is reportable.
Who reports to the Reportable Food Registry?
The responsible party — the person who submitted the FDA registration for the food facility — handling food for U.S. consumption.
Are FDA food recalls mandatory?
Most are voluntary. FDA can order a recall when there is a reasonable probability that a food is adulterated or misbranded and could cause serious adverse health consequences or death, and the company does not recall it voluntarily.
Does an undeclared allergen need an RFR report?
An undeclared major allergen in shipped product is a common reason for RFR reports and recalls, because it can cause serious reactions.
Sources
- FDA — Guidance: Questions and answers regarding the Reportable Food Registry (July 2017)
- Federal Register — FY2027 FSMA fee rates (July 30, 2026)
Requirements checked on November 12, 2026. This article is general information, not legal advice.