[ 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.

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1,232 matching recalls
DateClassFirmReasonQuality domain
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0324-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0327-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0330-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0311-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0317-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0326-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0319-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0320-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0310-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIFresenius Kabi Compounding, LLCD-0333-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-02-18Class IILee's CommissaryH-0496-2026Product may contain foreign material.Environmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0309-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0328-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0325-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0307-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIMG Foods-Compass GroupH-0495-2026foreign material (small hard plastic fragments)Environmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0314-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IITKS Co-pack Manufacturing, LLCH-0520-2026Possible coliforms, E.coli, and/or Pseudomonas aeruginosa contamination.Environmental Monitoring
2026-02-18Class IIVentura Foods LLCH-0504-2026Foreign material. During production, the firm found pieces of blue plastic in a filter.Environmental Monitoring
2026-02-18Class IITKS Co-pack Manufacturing, LLCH-0521-2026Possible coliforms, E.coli, and/or Pseudomonas aeruginosa contamination.Environmental Monitoring
2026-02-18Class IIVentura Foods LLCH-0503-2026Foreign material. During production, the firm found pieces of blue plastic in a filter.Environmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0315-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0329-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0313-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0316-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
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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.