Methodology & sources

Source

Every record on the Drug & Device Safety Atlas comes from the openFDA drug & device enforcement (recall) API, published by the U.S. Food & Drug Administration. Each record is an FDA recall enforcement report: one drug or device recall, identified by its FDA recall number.

What a recall is

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product on the market. It is a fact about an enforcement event. It is not a finding that any specific unit harmed anyone, and a recall does not establish causation. Most recalls are firm-initiated (voluntary) and most are Class II or III.

What the recall class means

• Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.
• Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
• Class III — the FDA judged the product is unlikely to cause harm.

The class is the FDA's risk judgment for the product category — not a measurement of harm to a specific person or unit.

Recall status

• Ongoing — the recall is still being carried out.
• Completed — the recalling firm's actions are complete (the FDA's review may still be open).
• Terminated — the FDA has closed the recall after judging the firm's actions effective.
• Pending — the recall classification is not yet final.

Lot & code information

A recall applies only to the specific lots / codes the FDA listed. Each recall page shows the FDA's lot/code information prominently so a person can compare it against the label on their product. A product that shares a name with a recalled one is not necessarily affected — only the listed lots are.

Honesty framing (hard rule)

This is a reference catalog. Every page reports the FDA's recorded enforcement facts and the FDA's risk class, and ROUTES to the FDA recall record and to a licensed pharmacist/prescriber for action. This site never tells anyone to start or stop a drug or device, never asserts that a specific unit caused harm, and is not medical advice. To report a problem you experienced, use FDA MedWatch. This is a hard release gate enforced in copy and in the JSON-LD on every page.

Current coverage: 12,421 recall records (2,738 drug, 9,683 device) since 2023-01-01. Data exported June 24, 2026.