[ 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
217
Class I (most serious)
167
Drug
515
Device
318
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.
1,496 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-04-01 | Class II | Mangalm LLCH-0626-2026 | Potential adulteration with erucic acid from mustard oil ingredient. | Risk Management & CAPA |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0608-2026 | Foreign material (aluminum pieces). | Environmental Monitoring |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0604-2026 | Foreign material (aluminum pieces). | Environmental Monitoring |
| 2026-04-01 | Class II | Ajinomoto Foods North America Inc.H-0593-2026 | Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide. | Environmental Monitoring |
| 2026-04-01 | Class II | Mangalm LLCH-0625-2026 | Potential adulteration with erucic acid from mustard oil ingredient. | Risk Management & CAPA |
| 2026-04-01 | Class II | Western Mixers Produce & Nuts, Inc.H-0589-2026 | Foreign object (glass) found inside sealed container of finished product. | Environmental Monitoring |
| 2026-04-01 | Class I | Distribuidora de Alimentos Sendero LLCH-0648-2026 | Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy | Documentation & Change Control |
| 2026-04-01 | Class II | Sevillo Fine Foods, IncH-0617-2026 | Product may contain foreign material (metal fragments). | Environmental Monitoring |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0607-2026 | Foreign material (aluminum pieces). | Environmental Monitoring |
| 2026-04-01 | Class II | Ajinomoto Foods North America Inc.H-0601-2026 | Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide. | Environmental Monitoring |
| 2026-04-01 | Class II | Savannah Bee Company Inc.H-0615-2026 | Undeclared Allergens: Soy & Wheat. The firm was notified by a customer that the product is labeled as Savannah Bee Company Honey BBQ Sauce "Mustard", but the product inside the bottle is a different flavor of BBQ sauce. After investigation, the firm determined that the product in the bottle is their Honey BBQ Sauce "Sweet". The BBQ sauce "Sweet" contains wheat and soy which is not listed on the BBQ Sauce "Mustard" label. | Documentation & Change Control |
| 2026-04-01 | Class II | Sevillo Fine Foods, IncH-0616-2026 | Product may contain foreign material (metal fragments). | Environmental Monitoring |
| 2026-04-01 | Class II | American Laboratories, LLCH-0610-2026 | Potential Salmonella contamination. | Environmental Monitoring |
| 2026-04-01 | Class II | Mangalm LLCH-0627-2026 | Potential adulteration with erucic acid from mustard oil ingredient. | Risk Management & CAPA |
| 2026-04-01 | Class II | BakkavorH-0618-2026 | Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers. | Environmental Monitoring |
| 2026-04-01 | Class I | Distribuidora de Alimentos Sendero LLCH-0649-2026 | Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy | Documentation & Change Control |
| 2026-04-01 | Class I | Nuts.com Inc.H-0632-2026 | Undeclared Allergen - Wheat and Soy (from Soy Lecithin). The ingredient statement and allergen information do not include wheat or soy. | Documentation & Change Control |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0609-2026 | Foreign material (aluminum pieces). | Environmental Monitoring |
| 2026-04-01 | Class II | Ajinomoto Foods North America Inc.H-0591-2026 | Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide. | Environmental Monitoring |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0606-2026 | Foreign material (aluminum pieces). | Environmental Monitoring |
| 2026-04-01 | Class II | Herbal Creations USAH-0602-2026 | Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient. | Documentation & Change Control |
| 2026-04-01 | Class II | American Laboratories, LLCH-0611-2026 | Potential Salmonella contamination. | Environmental Monitoring |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0605-2026 | Foreign material (aluminum pieces). | Environmental Monitoring |
| 2026-04-01 | Class II | American Laboratories, LLCH-0612-2026 | Potential Salmonella contamination. | Environmental Monitoring |
| 2026-04-01 | Class II | Western Mixers Produce & Nuts, Inc.H-0590-2026 | Foreign object (glass) found inside sealed container of finished product. | Environmental Monitoring |
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.