[ 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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839 matching recalls
DateClassFirmReasonQuality domain
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-0316-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIFresenius Kabi Compounding, LLCD-0337-2026Lack of Assurance of SterilityEnvironmental 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 IIFresenius Kabi Compounding, LLCD-0334-2026Lack of Assurance of SterilityEnvironmental Monitoring
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 IIFresenius Kabi Compounding, LLCD-0335-2026Lack of Assurance of SterilityEnvironmental 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 IIIUnichem Pharmaceuticals USA Inc.D-0306-2026Tablets/Capsules Imprinted with Wrong IDDocumentation & Change Control
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0323-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0308-2026Presence 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 IIPro Numb Tattoo Numbing Spray LLCD-0303-2026cGMP deviationsRisk Management & CAPA
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0321-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0331-2026Presence 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-0314-2026Presence 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-0330-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0312-2026Presence 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
2026-02-11Class IHANDELNINE GLOBAL LLCD-0332-2026CGMP Deviations: product found to contain lead.Risk Management & CAPA
2026-02-11Class IIGranules Pharmaceuticals Inc.D-0305-2026Presence of Foreign Tablets/Capsules—
2026-02-11Class IIUnichem Pharmaceuticals USA Inc.D-0301-2026cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.Validation & Qualification
2026-02-11Class IGreen Lumber Holdings, LLCD-0304-2026Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil—
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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.