FDA Enforcement Report

Key facts

Published by

U.S. Food and Drug Administration, weekly

Coverage

Classified recalls of drugs, biologics, devices, foods, veterinary products

Recall number prefixes

D drugs, B biologics, Z devices, F foods, V veterinary

Machine-readable access

openFDA enforcement endpoints for drugs, devices and foods

What is the FDA Enforcement Report?

The Enforcement Report is the public record of recalls monitored by the Food and Drug Administration (FDA). A recall enters the report once FDA has classified it as Class I, II or III, which can be some time after the company first acted.

It is far more complete than FDA press releases. Most recalls never receive a press release or news coverage, but classified recalls appear in the Enforcement Report regardless of size or class.

The report is searchable online, and the same records are available through openFDA, which adds harmonized fields such as NDC and brand name when a product can be matched.

What an Enforcement Report record contains

Each record describes one recalled product within a recall event:

• Recall number: a product-type letter, a sequence number and a year, such as D-0123-2024 for a drug.
• Event ID: groups all products recalled together in one recall event.
• Product description and code information: product name, strength, package details and affected lot numbers or expiration dates.
• Reason for recall: a free-text explanation such as failed impurity specifications, lack of sterility assurance or a labeling mix-up.
• Recalling firm and location, plus the distribution pattern, for example nationwide.
• Classification, classification date, report date, recall status and whether the recall was voluntary or FDA-mandated.

Why the Enforcement Report matters

It is the primary source for counting and tracking recalls:

• Supplier risk monitoring: procurement and quality teams track recalls by firm and facility over time.
• Competitive intelligence: a recall affecting a competing product or generic supplier can shift short-term demand to alternatives.
• Regulatory research: reasons for recall reveal recurring failure modes, such as nitrosamine impurities or sterility problems.
• Journalism and policy work: the report is the primary-source record behind recall counts.

Limitations of Enforcement Report data

Product details are largely free text. Many records carry no clean NDC or brand name, and openFDA harmonized fields are missing whenever a product cannot be matched, so searching by drug name or NDC alone misses recalls. A text search of the product description is usually needed as well.

Counts depend on the unit. One recall event can list dozens of product records, and records are updated as recall status changes, so snapshots taken on different dates will differ.