Monthly recall report · official FDA and CPSC data
U.S. product recalls in December 2025: the numbers
In December 2025, FDA's weekly Enforcement Reports listed 170 recall events covering 602 product records, 101 of them Class I (the most serious). CPSC announced 33 consumer-product recalls. The most common food recall cause was undeclared allergens (16 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 | 57 | 145 | 85 | 56 | 4 |
| Drugs | 24 | 62 | 1 | 53 | 8 |
| Medical devices | 89 | 395 | 15 | 371 | 9 |
| All FDA | 170 | 602 | 101 | 480 | 21 |
Class columns count product records, as FDA classifies each record.
Compared with last month and last year
| Measure | December 2025 | November 2025 | December 2024 |
|---|---|---|---|
| FDA recall events | 170 | 147 (+16%) | 85 (+100%) |
| FDA product records | 602 | 422 (+43%) | 197 (+206%) |
| Class I product records | 101 | 62 (+63%) | 21 (+381%) |
| Food recall events | 57 | 40 (+43%) | 23 (+148%) |
| Drug recall events | 24 | 24 (no change) | 20 (+20%) |
| Device recall events | 89 | 83 (+7%) | 42 (+112%) |
| CPSC recalls | 33 | 40 (−17%) | 21 (+57%) |
What caused food recalls in December 2025
Counted per recall event, by the main cause named in FDA's reason for recall.
| Cause | Events | Share |
|---|---|---|
| Undeclared allergens | 16 | 28% |
| Salmonella | 10 | 18% |
| Chemical contaminants or toxins | 7 | 12% |
| Other or labeling issues | 6 | 11% |
| Foreign material (metal, plastic, glass…) | 6 | 11% |
| Listeria monocytogenes | 5 | 9% |
| Other pathogens (Cyclospora, hepatitis A, botulism…) | 5 | 9% |
| E. coli (STEC) | 2 | 4% |
Which allergens were undeclared
One event can name more than one allergen.
| Cause | Events | Share |
|---|---|---|
| Soy | 4 | 24% |
| Milk | 3 | 18% |
| Tree nuts | 3 | 18% |
| Wheat | 3 | 18% |
| Sulfites | 2 | 12% |
| Peanut | 1 | 6% |
| Crustacean shellfish | 1 | 6% |
Firms with the most food product records
- CHETAK NEW YORK LLC — 52 product records in 1 event
- Moonlight Packing Corporation — 11 product records in 1 event
- A New Life Herbs, LLC — 9 product records in 1 event
- Great Lakes Cheese Co Inc — 7 product records in 1 event
- First & Last Tavern — 3 product records in 1 event
Class I food recalls
- Deep-brand Select Bhindi Cut Okra — Salmonella
- Sticker label — Listeria monocytogenes
- Whatcom Blue Sliced cheese — E. coli (STEC)
- Belevini BICHKI — Other pathogens (Cyclospora, hepatitis A, botulism…)
- Food to Live brand ORGANIC MORINGA LEAF POWDER — Salmonella
- Choceur Pecan Cranberry & Cinnamon Holiday Bark. — Undeclared allergens
- Locatelli Pecorino Romano Cheese Grated — Listeria monocytogenes
- 1) Wegmans Deluxe Mixed Nuts — Salmonella
- Senna Leaves F/c OG — Salmonella
- Face Rock Creamery Vampire Slayer Garlic Cheddar — Listeria monocytogenes
- Genepro Whey 4th Generation Plasma Treated Protein — Undeclared allergens
- Doughy brand Chocolate Chip Cookie Dough — Salmonella
Check a product: find the lot number · latest FDA food recalls · what to do if it matches
Why drugs were recalled in December 2025
| Cause | Events | Share |
|---|---|---|
| Impurities, contamination or particulates | 8 | 33% |
| Other reasons | 4 | 17% |
| Potency, dissolution or specification failures | 4 | 17% |
| Labeling or packaging errors | 3 | 13% |
| Manufacturing practice (CGMP) deviations | 3 | 13% |
| Lack of sterility assurance | 2 | 8% |
Class I drug recalls
- Famotidine Injection — Lack of sterility assurance
Consumer-product (CPSC) recalls in December 2025
| Cause | Recalls | Share |
|---|---|---|
| Suffocation, entrapment or strangulation | 8 | 24% |
| Fire or burn | 7 | 21% |
| Choking or ingestion | 6 | 18% |
| Falls | 5 | 15% |
| Laceration | 3 | 9% |
| Drowning | 3 | 9% |
| Other injury hazards | 1 | 3% |
Largest CPSC recalls by units
- INIU Power Banks — Fire and Burn Hazards
- Plantimex Mamisan Lidocaine Ointment Containers — Child Poisoning
- HydroJug 14-Ounce Children's Sport Tumblers — Choking Hazard
- Furnulem 8-Drawer Dressers — Tip-Over and Entrapment
- Blue Wave Above-Ground Pools 48 Inches and Taller — Drowning Hazard
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, December 2025: FDA & CPSC Recalls by the Numbers,” analysis of openFDA and CPSC recall data, www.recalledornot.com/recall-report/2025-12
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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.