Monthly recall report · official FDA and CPSC data

U.S. product recalls in May 2025: the numbers

In May 2025, FDA's weekly Enforcement Reports listed 116 recall events covering 293 product records, 63 of them Class I (the most serious). CPSC announced 37 consumer-product recalls. The most common food recall cause was undeclared allergens (15 events).

116FDA recall events−35% vs previous month (178)−32% vs a year earlier (171)
63Class I FDA product records+13% vs previous month (56)−39% vs a year earlier (103)
30FDA food recall events−45% vs previous month (55)−27% vs a year earlier (41)
37CPSC consumer-product recalls+9% vs previous month (34)+42% vs a year earlier (26)

FDA recalls by product type and class

An FDA recall event is one firm's recall action; it can list many product records (sizes, flavors, lots). Class I means a reasonable probability of serious harm or death; Class II, temporary or reversible harm; Class III, unlikely to cause harm.

FDA recall events and product records by type and class, May 2025
TypeEventsProduct recordsClass IClass IIClass III
Food & cosmetics307824540
Drugs21581570
Medical devices65157381190
All FDA116293632300

Class columns count product records, as FDA classifies each record.

Compared with last month and last year

May 2025 compared with the previous month and the same month a year earlier
MeasureMay 2025April 2025May 2024
FDA recall events116178 (−35%)171 (−32%)
FDA product records293420 (−30%)502 (−42%)
Class I product records6356 (+13%)103 (−39%)
Food recall events3055 (−45%)41 (−27%)
Drug recall events2135 (−40%)36 (−42%)
Device recall events6588 (−26%)94 (−31%)
CPSC recalls3734 (+9%)26 (+42%)

What caused food recalls in May 2025

Counted per recall event, by the main cause named in FDA's reason for recall.

Food recall events by cause, May 2025
CauseEventsShare
Undeclared allergens1550%
Foreign material (metal, plastic, glass…)827%
Salmonella413%
Other or labeling issues13%
Listeria monocytogenes13%
Chemical contaminants or toxins13%

Which allergens were undeclared

One event can name more than one allergen.

Undeclared allergens in food recall events, May 2025
CauseEventsShare
Milk528%
Tree nuts422%
Soy317%
Wheat211%
Egg16%
Peanut16%
Sesame16%
Sulfites16%

Firms with the most food product records

  1. Wells Enterprises, Inc. — 22 product records in 1 event
  2. Knockroe Inc — 12 product records in 1 event
  3. Frobright Salsary, LLC — 8 product records in 1 event
  4. LAMB WESTON Inc — 4 product records in 1 event
  5. Dinstuhl's Fine Candy Company, Inc. — 3 product records in 1 event

Class I food recalls

Check a product: find the lot number · latest FDA food recalls · what to do if it matches

Why drugs were recalled in May 2025

Drug recall events by reason, May 2025
CauseEventsShare
Lack of sterility assurance524%
Manufacturing practice (CGMP) deviations524%
Impurities, contamination or particulates419%
Potency, dissolution or specification failures314%
Other reasons210%
Labeling or packaging errors210%

Class I drug recalls

Consumer-product (CPSC) recalls in May 2025

CPSC recalls by hazard, May 2025
CauseRecallsShare
Fire or burn1130%
Choking or ingestion924%
Suffocation, entrapment or strangulation822%
Falls411%
Crash or impact injury38%
Other injury hazards25%

Largest CPSC recalls by units

Check a product on CPSC · child product recalls

Method and sources

  • FDA: openFDA enforcement data for food, drugs and devices, by report_date — the weekly FDA Enforcement Report the record appeared in, not the day the firm began the recall. FDA also publishes records after classification, so a recall can appear weeks after it started.
  • CPSC: the CPSC Recalls API, by recall date. Unit counts are the largest figure CPSC states for each recall.
  • Causes are grouped by keyword matching on the official reason or hazard text, first match wins. Treat category shares as approximate; the linked records are authoritative.
  • Not included: USDA FSIS meat, poultry and egg-product recalls, and NHTSA vehicle recalls.
  • Recent months are refreshed every six hours for about six weeks while agencies add late records; older months are refreshed monthly.

How to cite this report

You are welcome to quote these figures with a link to this page:

Recalled or Not?, “U.S. Recall Report, May 2025: FDA & CPSC Recalls by the Numbers,” analysis of openFDA and CPSC recall data, www.recalledornot.com/recall-report/2025-05

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This site is independent and is not affiliated with FDA or CPSC. Counts summarize official records and are not a safety verdict for any product; always check the official notice.