[ 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.
3,465 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-06-10 | Class II | Baxter Healthcare CorporationZ-2262-2026 | Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc. | Validation & Qualification |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0566-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0567-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0559-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0575-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0571-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0572-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0560-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | CareFusion 303, Inc.Z-2304-2026 | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0565-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Spectra Medical Devices, LlcD-0554-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0558-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class I | JCB Flavors, LLCH-0885-2026 | Products may be potentially contaminated with Salmonella. | Environmental Monitoring |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0557-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-03 | Class II | Fly By Jing Inc.H-0854-2026 | Possible cross-contamination resulting in undeclared allergen ingredient (Peanut) | Environmental Monitoring |
| 2026-06-03 | Class I | Wawa Beverage CompanyH-0858-2026 | Undeclared Milk Allergen, | Documentation & Change Control |
| 2026-06-03 | Class I | Wawa Beverage CompanyH-0855-2026 | Undeclared Milk Allergen, | Documentation & Change Control |
| 2026-06-03 | Class I | Legacy Bakehouse LLCH-0851-2026 | Products were made with recalled California Dairies milk powder due to Salmonella. | Environmental Monitoring |
| 2026-06-03 | Class I | Legacy Bakehouse LLCH-0852-2026 | Products were made with recalled California Dairies milk powder due to Salmonella. | Environmental Monitoring |
| 2026-06-03 | Class I | Honeyville, IncH-0849-2026 | Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products. | Environmental Monitoring |
| 2026-06-03 | Class I | Wawa Beverage CompanyH-0857-2026 | Undeclared Milk Allergen, | Documentation & Change Control |
| 2026-06-03 | Class I | Wawa Beverage CompanyH-0856-2026 | Undeclared Milk Allergen, | Documentation & Change Control |
| 2026-06-03 | Class I | Legacy Bakehouse LLCH-0850-2026 | Products were made with recalled California Dairies milk powder due to Salmonella. | Environmental Monitoring |
| 2026-06-03 | Class III | AbbVie Inc.D-0551-2026 | Failed Stability Specifications | Validation & Qualification |
| 2026-06-03 | Class III | AVEVA Drug Delivery Systems, Inc.D-0550-2026 | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. | Validation & Qualification |
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.