Monthly recall report · official FDA and CPSC data
U.S. product recalls in September 2025: the numbers
In September 2025, FDA's weekly Enforcement Reports listed 151 recall events covering 405 product records, 68 of them Class I (the most serious). CPSC announced 20 consumer-product recalls. The most common food recall cause was undeclared allergens (18 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 | 41 | 93 | 26 | 49 | 18 |
| Drugs | 30 | 63 | 7 | 55 | 1 |
| Medical devices | 80 | 249 | 35 | 143 | 71 |
| All FDA | 151 | 405 | 68 | 247 | 90 |
Class columns count product records, as FDA classifies each record.
Compared with last month and last year
| Measure | September 2025 | August 2025 | September 2024 |
|---|---|---|---|
| FDA recall events | 151 | 143 (+6%) | 123 (+23%) |
| FDA product records | 405 | 422 (−4%) | 596 (−32%) |
| Class I product records | 68 | 98 (−31%) | 67 (+1%) |
| Food recall events | 41 | 44 (−7%) | 31 (+32%) |
| Drug recall events | 30 | 27 (+11%) | 9 (+233%) |
| Device recall events | 80 | 72 (+11%) | 83 (−4%) |
| CPSC recalls | 20 | 24 (−17%) | 18 (+11%) |
What caused food recalls in September 2025
Counted per recall event, by the main cause named in FDA's reason for recall.
| Cause | Events | Share |
|---|---|---|
| Undeclared allergens | 18 | 44% |
| Other or labeling issues | 9 | 22% |
| Processing, temperature or sanitation problems | 5 | 12% |
| Listeria monocytogenes | 4 | 10% |
| Salmonella | 3 | 7% |
| Other pathogens (Cyclospora, hepatitis A, botulism…) | 2 | 5% |
Which allergens were undeclared
One event can name more than one allergen.
| Cause | Events | Share |
|---|---|---|
| Wheat | 6 | 22% |
| Soy | 6 | 22% |
| Tree nuts | 4 | 15% |
| Sesame | 4 | 15% |
| Milk | 3 | 11% |
| Peanut | 2 | 7% |
| Egg | 1 | 4% |
| Sulfites | 1 | 4% |
Firms with the most food product records
- Hi-Tech Pharmaceuticals Inc. — 16 product records in 1 event
- The Candy Barn — 9 product records in 1 event
- PRIMO NO. 1 IN PRODUCE, INC — 5 product records in 1 event
- Fresh & Ready Foods LLC — 4 product records in 1 event
- Gelsons — 4 product records in 1 event
Class I food recalls
- Cucumbers Peeled/Dice 1/4" KBS — Salmonella
- Tuscan Artichoke and Mozzarella Salad — Undeclared allergens
- Wegmans Grilling Camembert with Tapenade & Roasted — Listeria monocytogenes
- 1) Middlefield Original Cheese Co-op 100% Grass-Fed — Listeria monocytogenes
- Deep Sprouted Mat — Salmonella
- Endico brand MIXED VEGETABLES — Listeria monocytogenes
- Neuhaus Brand Original Belgian Chocolate — Undeclared allergens
- Honey Balsamic dressing — Undeclared allergens
- Organic Mango Freeze Dried Powder — Salmonella
- Brie Royal Faucon — Listeria monocytogenes
- Salad Kit labeled as follows: Taylor FARMS Honey — Undeclared allergens
Check a product: find the lot number · latest FDA food recalls · what to do if it matches
Why drugs were recalled in September 2025
| Cause | Events | Share |
|---|---|---|
| Impurities, contamination or particulates | 11 | 37% |
| Potency, dissolution or specification failures | 6 | 20% |
| Manufacturing practice (CGMP) deviations | 4 | 13% |
| Other reasons | 3 | 10% |
| Lack of sterility assurance | 3 | 10% |
| Labeling or packaging errors | 3 | 10% |
Class I drug recalls
- PeriGiene — Lack of sterility assurance
- 0.9% Sodium Chloride Injection USP — Impurities, contamination or particulates
- Cyclobenzaprine Hydrochloride Tablets — Labeling or packaging errors
Consumer-product (CPSC) recalls in September 2025
| Cause | Recalls | Share |
|---|---|---|
| Fire or burn | 10 | 50% |
| Suffocation, entrapment or strangulation | 5 | 25% |
| Choking or ingestion | 3 | 15% |
| Laceration | 1 | 5% |
| Crash or impact injury | 1 | 5% |
Largest CPSC recalls by units
- Sunbeam Products More than One Million Oster French Door — Burn Hazard
- Persilux Brand Zebra Blinds — Strangulation and Entanglement Hazards
- Epoca International Paris Hilton Mini Beauty Fridges — Fire and Burn Hazards
- Five Below Tabletop Fire Pits — Serious Burn Injury from Flame Jetting
- Makita U.S.A., Inc. Cordless Grease Guns and Grease Gun — Laceration 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, September 2025: FDA & CPSC Recalls by the Numbers,” analysis of openFDA and CPSC recall data, www.recalledornot.com/recall-report/2025-09
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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.