FDA drug recalls

What the indexed enforcement stream contains

Recall classification: Class I, Class II and Class III

The FDA assigns each recall a classification expressing the agency's regulatory assessment of the recall event. These are administrative tiers, not scores of how dangerous a product is to any specific person, and they cannot be translated into personal risk. In the indexed dataset:

• Class I — the most serious regulatory category, 11 records.
• Class II — the intermediate category, and the tier most routine recall actions fall into, 213 records.
• Class III — the least serious category, typically applied to recalls of a more administrative character, 25 records.

Each tier page carries that tier's own firm index, its multi-record enforcement events, its recurring products and its report-month distribution, alongside the complete record listing. For the precise definitions of every field and tier used across these pages see the regulatory intelligence glossary, and for the data lineage the methodology and FDA data sources pages.

Recall status in the indexed data

Each enforcement report carries a status describing where the recall sits in its lifecycle. Across the 250 indexed records the breakdown is 250 ongoing , and no record yet carries a termination date. A status of "terminated" means the FDA has recorded the recall as concluded; "ongoing" means the action was still in progress when the report was published. Because the ingested window is recent, a single status can dominate — the live value should always be confirmed against the official source.

Enforcement events covering more than one recall number

One FDA event ID is one enforcement action; one recall number is one recalled product configuration. These 31 events each cover several recall numbers — usually different strengths, package sizes or NDCs of the same action. Each record keeps its own page because each has its own recall number, classification and dates.

Firms with more than one indexed recall

39 of the 86 recalling firms in the indexed data appear on more than one enforcement report. Each links to the firm's regulatory profile, which aggregates its recall and shortage records across the indexed datasets. These counts are coverage-limited activity signals over the ingested window — they are not quality ratings and carry no judgement about a company.

Products named by more than one recall record

Matched on the product-name prefix of the FDA's own product description, so different strengths and package sizes of the same product group together. 38 products in the indexed data are named by more than one record.

Enforcement reports by month

Report-date months across the indexed data. The report date is when the FDA published the enforcement report, normally later than the date the firm began the recall — a median of 23 days later in this dataset.

Latest enforcement reports

The 25 most recent enforcement reports in the indexed dataset, newest first by report date. Each links to its own record page and, from there, to the verifiable openFDA source.

Records without a classification (1)

Enforcement reports the source publishes without a classification. They are listed here because the Class I, II and III indexes cannot cover them, and every record must remain reachable from an index page.

Records with no shared event, firm or product (40)

These records are the only recall from their firm, the only one naming their product, and the only recall number under their event ID. Nothing in the relation graph links them strongly, so the hub links them directly rather than leaving them to the weakest relation buckets.