FDA Class I drug recalls

What this tier looks like in the indexed data

Firms with Class I records

The 9 firms named on these records, most records first. Each links to the firm's regulatory profile, which aggregates its recall and shortage records across the indexed datasets. Counts are coverage-limited activity signals over the ingested window, never quality ratings.

Enforcement events covering more than one Class I recall number

The FDA files one event ID per enforcement action and one recall number per recalled product configuration, so a single action can appear as several records. These are the 2 multi-record events in this tier.

Products named in more than one Class I record

Matched on the product-name prefix of the FDA's own product description, so different strengths and packages of the same product group together.

When these recalls were reported

Report-date months across the 11 records in this tier. The report date is when the FDA published the enforcement report, which is normally later than the date the firm began the recall.

All Class I records (11)

Newest first by report date. Each row links to the record page, which carries the regulatory snapshot, the FDA's verbatim reason field, the identifiers extracted from the product description, and the other records that share its event, firm or product.

Other recall views

Class II recalls, Class III recalls, or the recall hub for the namespace-level counts, the enforcement-event index and the firm index. Field definitions are in the regulatory intelligence glossary; the data lineage is in the methodology and FDA data sources pages.