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FDA signal extraction — not news summaries.
simplyFDA continuously monitors openFDA and official FDA feeds, then uses AI to extract what each update actually means for Regulatory Affairs, Clinical Operations, QA, and Pharmacovigilance teams — with the original FDA source one click away.
Updates indexed
878
This week
0
Critical signals
3
Last ingestion
Sep 22 · 05:07 UTC
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Critical
Highest-priority FDA signals
Food/Recall
CriticalNARA ORGANICS RECALLS ALL LOTS OF NARA INFANT FORMULA BECAUSE OF POSSIBLE HEALTH RISK
Jun 13, 2026·FDA Recalls, Market Withdrawals & Safety Alerts
Devices/Recall
CriticalSurgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads
May 5, 2026·FDA MedWatch Safety Alerts
Devices/Safety Alert
CriticalEarly Alert: Thoracic Stent Graft Issue from Bolton Medical
Apr 28, 2026·MedWatch
Live feed
Latest FDA intelligence
1w ago
Other/Warning Letter
· 1w agoWarning Letter — Bausch & Lomb Inc.
Bausch & Lomb Inc.
Bausch & Lomb Inc.
Medium
1w agoFood/Warning Letter
· 1w agoWarning Letter — H2 BEV, LLC and H2 RENU, INC
H2 BEV, LLC, H2 RENU, INC.
H2 BEV, LLC, H2 RENU, INC.
Medium
1w agoDrugs/Safety Alert
· 1w agoFDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use
Allergan Aesthetics
Allergan Aesthetics
Medium
1w agoDrugs/Recall
· 1w agoBaxter Healthcare Corporation — Class II: Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Sing
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Medium
1w agoDrugs/Recall
· 1w agoBaxter Healthcare Corporation — Class II: Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Medium
1w agoDrugs/Recall
· 1w agoBaxter Healthcare Corporation — Class II: Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg to
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Medium
1w agoDrugs/Recall
· 1w agoBaxter Healthcare Corporation — Class II: CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Medium
1w agoDevices/Recall
· 1w agoMedline Industries, LP — Class II: Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2)
Medline Industries, LP
Medline Industries, LP
Medium
1w agoDevices/Recall
· 1w agoCardinal Health 200, LLC — Class II: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)
Cardinal Health 200, LLC, BD
Cardinal Health 200, LLC, BD
Medium
1w agoFood/Recall
· 1w agoUkrop's Homestyle Foods LLC — Class II: Bread Pudding with Vanilla Sauce - KIT NET WT 4 LB (1.81Kg) UPC 7 22515 91732 0 Ukrop's Ho
Ukrop's Homestyle Foods LLC
Ukrop's Homestyle Foods LLC
Medium
1w agoDrugs/Recall
· 1w agoSupernus Pharmaceuticals, Inc. — Class III: Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufact
Supernus Pharmaceuticals, Inc., Catalent Pharma Solutions
Supernus Pharmaceuticals, Inc., Catalent Pharma Solutions
Medium
1w agoDevices/Recall
· 1w agoAVID Medical, Inc. — Class II: Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (k
AVID Medical, Inc., Medicom
AVID Medical, Inc., Medicom
Medium
Coverage
FDA domains we monitor
Drugs
Approvals, label changes, MedWatch alerts, drug enforcement reports.
Devices
510(k), PMAs, MDR adverse event reports, recalls and safety alerts.
Biologics
BLAs, cell & gene therapy, vaccines, and CBER enforcement signals.
Warning Letters
Pattern analysis of recurring findings, observations, and CAPA failures.
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