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).
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.
| Type | Events | Product records | Class I | Class II | Class III |
|---|---|---|---|---|---|
| Food & cosmetics | 30 | 78 | 24 | 54 | 0 |
| Drugs | 21 | 58 | 1 | 57 | 0 |
| Medical devices | 65 | 157 | 38 | 119 | 0 |
| All FDA | 116 | 293 | 63 | 230 | 0 |
Class columns count product records, as FDA classifies each record.
Compared with last month and last year
| Measure | May 2025 | April 2025 | May 2024 |
|---|---|---|---|
| FDA recall events | 116 | 178 (−35%) | 171 (−32%) |
| FDA product records | 293 | 420 (−30%) | 502 (−42%) |
| Class I product records | 63 | 56 (+13%) | 103 (−39%) |
| Food recall events | 30 | 55 (−45%) | 41 (−27%) |
| Drug recall events | 21 | 35 (−40%) | 36 (−42%) |
| Device recall events | 65 | 88 (−26%) | 94 (−31%) |
| CPSC recalls | 37 | 34 (+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.
| Cause | Events | Share |
|---|---|---|
| Undeclared allergens | 15 | 50% |
| Foreign material (metal, plastic, glass…) | 8 | 27% |
| Salmonella | 4 | 13% |
| Other or labeling issues | 1 | 3% |
| Listeria monocytogenes | 1 | 3% |
| Chemical contaminants or toxins | 1 | 3% |
Which allergens were undeclared
One event can name more than one allergen.
| Cause | Events | Share |
|---|---|---|
| Milk | 5 | 28% |
| Tree nuts | 4 | 22% |
| Soy | 3 | 17% |
| Wheat | 2 | 11% |
| Egg | 1 | 6% |
| Peanut | 1 | 6% |
| Sesame | 1 | 6% |
| Sulfites | 1 | 6% |
Firms with the most food product records
- Wells Enterprises, Inc. — 22 product records in 1 event
- Knockroe Inc — 12 product records in 1 event
- Frobright Salsary, LLC — 8 product records in 1 event
- LAMB WESTON Inc — 4 product records in 1 event
- Dinstuhl's Fine Candy Company, Inc. — 3 product records in 1 event
Class I food recalls
- Bonya Raspberry Yogurt Parfait — Undeclared allergens
- Trader Joe's Sesame Miso Salad with Salmon — Undeclared allergens
- H&C Farms Raw Premium Tomatoes — Salmonella
- Tomatoes — Salmonella
- Enoki Mushroom in a — Listeria monocytogenes
- Zeke's Daddy's Granola — Undeclared allergens
- Heinen's Honey Roasted Peanuts — Other or labeling issues
- Lactoferrin as Apolactoferrin 60 vegetarian capsules — Undeclared allergens
- Ankimo branded Monkfish Liver — Undeclared allergens
- Yellowstone Brown Sugar Molasses Baked Beans — Undeclared allergens
- Caraluzzi's Italian Style Seafood Burgers — Undeclared allergens
- Organic traditions brand JUMBO PUMPKIN SEEDS — Salmonella
Check a product: find the lot number · latest FDA food recalls · what to do if it matches
Why drugs were recalled in May 2025
| Cause | Events | Share |
|---|---|---|
| Lack of sterility assurance | 5 | 24% |
| Manufacturing practice (CGMP) deviations | 5 | 24% |
| Impurities, contamination or particulates | 4 | 19% |
| Potency, dissolution or specification failures | 3 | 14% |
| Other reasons | 2 | 10% |
| Labeling or packaging errors | 2 | 10% |
Class I drug recalls
- Ropivacaine Hydrochloride Injection — Impurities, contamination or particulates
Consumer-product (CPSC) recalls in May 2025
| Cause | Recalls | Share |
|---|---|---|
| Fire or burn | 11 | 30% |
| Choking or ingestion | 9 | 24% |
| Suffocation, entrapment or strangulation | 8 | 22% |
| Falls | 4 | 11% |
| Crash or impact injury | 3 | 8% |
| Other injury hazards | 2 | 5% |
Largest CPSC recalls by units
- SharkNinja 1.8 Million Foodi Multi-Function Pressure Cookers — Burn Hazard
- Igloo 90 Qt. Rolling Coolers — Fingertip Amputation and Crushing
- WeHwupe Adult Portable Bed Rails — Entrapment and Asphyxiation Hazards
- Baseus Portable Chargers — Fire Hazard
- KICIMPRO Brand Kitchen Faucets — Dangerous Lead Exposure for Young
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.