the database
The free, public FDA enforcement database.
4,281 FDA actions indexed and AI-summarized from public FDA records, updated daily and cited back to the original source. Search it, browse it, or get it delivered to your inbox.
223Warning Letters
3,660Recalls
184Approvals
905Companies
Warning Letters →
Every FDA Warning Letter, summarized with cited violations and company history.
Recalls →
Drug and medical device recalls, filterable by classification and product category.
Approvals →
FDA drug approval submissions, filterable by year and review pathway.
Companies →
Every company entity Argus tracks, with a full FDA enforcement timeline.
Most recent 20 actions
- BIOCON PHARMA — ANDA approval: NINTEDANIB ESYLATEApproval · August 19, 2026
- ANNORA PHARMA — ANDA approval: LISINOPRILApproval · August 20, 2026
- EPIC PHARMA LLC — ANDA approval: RIVAROXABANApproval · August 19, 2026
- ZYDUS PHARMS — ANDA approval: ASCORBIC ACIDApproval · August 20, 2026
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078,…Recall · August 19, 2026
- BioFire Diagnostics, LLC — Class II recall: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PC…Recall · August 19, 2026
- OBP Medical Corporation — Class II recall: OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small…Recall · August 19, 2026
- Covidien, LP — Class II recall: Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31…Recall · August 19, 2026
- Cardinal Health 200, LLC — Class II recall: Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Numb…Recall · August 19, 2026
- Covidien, LP — Class II recall: Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623Recall · August 19, 2026
- Bioporto Diagnostics A/S — Class II recall: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test Syste…Recall · August 19, 2026
- Straumann USA LLC — Class II recall: GM Helix Implant, Endosseous Dental Implant Article No. 109.984Recall · August 19, 2026
- Cardinal Health 200, LLC — Class II recall: Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Numbe…Recall · August 19, 2026
- Waldemar Link GmbH & Co. KG (Mfg Site) — Class II recall: Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rota…Recall · August 19, 2026
- BD SWITZERLAND SARL — Class II recall: 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235…Recall · August 19, 2026
- Spacelabs Healthcare, Inc. — Class II recall: Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number:…Recall · August 19, 2026
- W L Gore & Associates, Inc. — Class II recall: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, se…Recall · August 19, 2026
- Cardinal Health 200, LLC — Class II recall: Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMBRecall · August 19, 2026
- Straumann USA LLC — Class II recall: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid,…Recall · August 19, 2026
- Covidien, LP — Class II recall: V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336…Recall · August 19, 2026
Stats as of 2026-08-27 · programmatic access at /api/stats.json