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Recall → Facility Trace

RegDataLab Team6 min read

When a recall is announced, one of the first questions is: which facility produced the affected product? FDA doesn't always publish this directly in the enforcement record. fda_recall_facility_trace bridges this gap by cross-referencing the recalling firm against facility registrations and returning candidate facilities with confidence scores.

MCP tool calls — your AI assistant calls these automatically. You can also invoke them via the MCP protocol.

Running a trace

fda_recall_facility_trace({ "recall_number": "D-0591-2025" })

Sample response:

{
  "recall": {
    "recall_number": "D-0591-2025",
    "classification": "Class II",
    "recalling_firm": "Pfizer Inc",
    "product_description": "Eliquis (apixaban) Tablets, 5 mg, ..."
  },
  "candidate_facilities": [
    {
      "fei": "3002807852",
      "firm_name": "Pfizer Inc",
      "city": "New York",
      "state": "NY",
      "confidence": "high",
      "match_method": "exact_firm_name"
    },
    {
      "fei": "3004336298",
      "firm_name": "Pfizer Manufacturing Belgium NV",
      "city": "Puurs",
      "country": "BE",
      "confidence": "medium",
      "match_method": "alias"
    }
  ],
  "caveats": [
    "Facility matching is based on firm name similarity — not confirmed by FDA linkage.",
    "Multiple facilities may be candidates; confidence indicates match strength, not certainty."
  ]
}

Interpreting confidence levels

The confidence field indicates how strong the name match is between the recalling firm and the facility record:

  • high — exact or near-exact name match. Likely the right facility, but not FDA-confirmed.
  • medium — matched via company alias or fuzzy similarity. Plausible but warrants verification.
  • low — weak match. Treat as a lead, not a conclusion.

The caveats array always accompanies the results. These are not boilerplate — they describe the specific limitations of the matching method used. Always surface them to end users.

What to do with the results

  1. Take the high-confidence FEIs and call fda_get_facility to get full facility details and risk summaries.
  2. For medium-confidence matches, check whether the facility's product list (via fda_facility_products) aligns with the recalled product.
  3. Store the recall number + FEI + confidence together for audit trails.
  4. If no high-confidence matches are returned, the recalling firm may not have a registered facility in the database (common for distributors vs. manufacturers).

When the trace finds nothing

Not every recall maps to a facility. Some recalls are issued by distributors or importers who don't hold their own FEI. In these cases the response will have an empty candidate_facilities array and a caveat explaining why. This is expected behavior, not an error.

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