[ FDA ENFORCEMENT INTELLIGENCE ]
Learn from the record. Every FDA recall is a quality signal.
Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.
1,000
Total recalls
214
Class I (most serious)
167
Drug
520
Device
313
Food / supplement / cosmetic
Last 12 months · latest report 2026-07-22 · source: openFDA enforcement
RECALLS BY CLASSIFICATION · MONTHLY
RECALL REASONS BY QUALITY DOMAIN
Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.
1,475 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2025-08-13 | Class II | Dollar General CorporationH-0410-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
| 2025-08-13 | Class II | Dollar General CorporationH-0402-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
| 2025-08-13 | Class II | Dollar General CorporationH-0409-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
| 2025-08-13 | Class II | Dollar General CorporationH-0407-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
| 2025-08-13 | Class II | Dollar General CorporationH-0415-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
| 2025-08-13 | Class I | Doehler North America, Inc.H-0394-2025 | Listeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-13 | Class I | Navarro Pecan Holdings, LLCH-0379-2025 | Pecans have the potential to be contaminated with Salmonella, | Environmental Monitoring |
| 2025-08-13 | Class II | OHIO HEALTH MOTHER MILK BANKH-0386-2025 | Inaccurate temperature reading from a thermometer on one pasteurization machine | — |
| 2025-08-13 | Class II | Dollar General CorporationH-0413-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
| 2025-08-13 | Class III | Cesarina Bakery, IncH-0393-2025 | Allergen not listed in the Contains statement: Sesame | Documentation & Change Control |
| 2025-08-13 | Class II | QUEEN BEE GARDENSH-0384-2025 | Product may have small flakes of stainless steel in product. | — |
| 2025-08-06 | Class II | Reisman Bros BakeryH-0373-2025 | Undeclared wheat and soy | Documentation & Change Control |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0431-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class II | Reisman Bros BakeryH-0371-2025 | Undeclared wheat and soy | Documentation & Change Control |
| 2025-08-06 | Class II | Reisman Bros BakeryH-0367-2025 | Undeclared wheat and soy | Documentation & Change Control |
| 2025-08-06 | Class III | NOVACAB SAPI DE CVH-0342-2025 | Multiple cake products contain goat milk, which was labeled as "milk" | Documentation & Change Control |
| 2025-08-06 | Class II | Reisman Bros BakeryH-0355-2025 | Undeclared wheat and soy | Documentation & Change Control |
| 2025-08-06 | Class II | Reisman Bros BakeryH-0362-2025 | Undeclared wheat | Documentation & Change Control |
| 2025-08-06 | Class II | Reisman Bros BakeryH-0368-2025 | Undeclared wheat and soy | Documentation & Change Control |
| 2025-08-06 | Class II | Reisman Bros BakeryH-0375-2025 | Undeclared wheat | Documentation & Change Control |
| 2025-08-06 | Class II | Reisman Bros BakeryH-0356-2025 | Undeclared wheat | Documentation & Change Control |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0426-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class II | Moon N Sea GA LLCH-0353-2025 | RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary conditions. | Risk Management & CAPA |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0437-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class II | Reisman Bros BakeryH-0378-2025 | Undeclared wheat | Documentation & Change Control |
Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.