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There were 1,956 press releases posted in the last 24 hours and 458,343 in the last 365 days.

U.S. Food and Drug Administration Press Releases

6,959 Press Releases

Published on July 16, 2025 - 03:49 GMT

Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen

Docket Number: FDA-2024-D-5942 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research This guidance document provides you, blood establishments that collect blood and blood components, including Source Plasma, with FDA’s …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 16, 2025 - 02:47 GMT

Scope Health Inc - 695085 - 07/09/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Tom Freyne Scope Health Inc 79 Madison Ave, Fl 8 New York, NY 10016 United States hello@optase.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 16, 2025 - 02:47 GMT

Thea Pharma, Inc. - 712416 - 07/09/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Susan K. Benton Recipient Title President Thea Pharma, Inc. 303 Wyman Street, Suite 205 Waltham, MA 02451 United States (b)(6), (b)(7)(C) Issuing Office: Center for Drug Evaluation and …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 16, 2025 - 02:46 GMT

Revitalize Energy, Inc. - 712417 - 07/09/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Kyle Guinness Revitalize Energy, Inc. 6401 Penn Ave. Suite 300 Pittsburgh, PA 15206 United States (b)(6), (b)(7)(C) Issuing Office: Center for Drug Evaluation and Research (CDER) United …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 16, 2025 - 02:46 GMT

EyeTech One, LLC - 712438 - 07/09/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Alvaro E. Arenas, AMBR EyeTech One, LLC 8833 Cypress Preserve PL Fort Meyers, FL 33912 United States (b)(6), (b)(7)(C) Issuing Office: Center for Drug Evaluation and Research (CDER) United …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 16, 2025 - 02:46 GMT

Covalent Medical - 695839 - 07/09/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Clint Worley, COO Covalent Medical 24600 Millstream Drive, Ste 410 Aldie, VA 20105 United States CWORLEY@focusvitamins.com Issuing Office: Center for Drug Evaluation and Research (CDER) …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 16, 2025 - 02:46 GMT

7Tabz Retail, LLC - 709546 - 06/25/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Jonathan Daye Recipient Title Zachary Daye 7Tabz Retail, LLC 5525 Johns Road Tampa, FL 33634 United States shop@pop7tabz.com Issuing Office: Center for Drug Evaluation and Research (CDER) …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 16, 2025 - 02:46 GMT

Royal Diamond Imports, Inc. - 709540 - 06/25/2025

Delivery Method: Via Email Product: Drugs Food & Beverages Recipient: Recipient Name Amir Surani Recipient Title Rafeeq Manjiyani Royal Diamond Imports, Inc. 11424 Reeder Road Dallas, TX 75229-2108 United States Sales@roxytabs.com Issuing Office: Human …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 16, 2025 - 02:46 GMT

Hydroxie, LLC - 709661 - 06/25/2025

Delivery Method: VIA EMAIL AND UPS Product: Drugs Food & Beverages Recipient: Recipient Name Tim R. Shaw Hydroxie, LLC 306 W El Norte Pkwy STE N 92 Escondido, CA 92026 United States support@hydroxie.com Issuing Office: Center for Drug Evaluation and …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 16, 2025 - 02:46 GMT

Drug Trials Snapshot: VANRAFIA

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 16, 2025 - 02:44 GMT

FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine

FDA News Release Alkaloid known as 7-OH is not a lawful dietary supplement, food additive, or ingredient in any approved drug For Immediate Release: July 15, 2025 The U.S. Food and Drug Administration today announced seven recent warning letters sent to …

Distribution channels: Food & Beverage Industry
Published on July 16, 2025 - 02:33 GMT

Krasniy Oktyabr Inc. USA Issues Alert on Eviscerate Dry Salted Vobla “Aral Silver”

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry
Published on July 15, 2025 - 14:05 GMT

BD Issues Update to Voluntary Global Recall of Alaris™ and BD Alaris™ Pump Modules Serviced with Legacy Bezel Kit Assemblies

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

Distribution channels: Food & Beverage Industry
Published on July 15, 2025 - 10:44 GMT

UPDATE - Sandoz Inc. Issues Voluntary Nationwide Recall Expansion of One Additional Lot of Cefazolin for Injection Due to Product ...

Summary Company Announcement Date: July 14, 2025 FDA Publish Date: July 14, 2025 Reason for Announcement: Recall Reason Description Vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection Company Name: Sandoz, Inc …

Distribution channels: Food & Beverage Industry
Published on July 15, 2025 - 10:44 GMT

YoCrunch® Products Voluntarily Recalled by Danone U.S. Due to Potential Presence of Plastic Pieces in Dome Topper

YOCRUNCH STRAW W/GRANOLA 6OZ (UPC 46675000105) 2025.07.07, 2025.07.12, 2025.07.26, 2025.08.03, 2025.08.08, 2025.08.19, 2025.08.22, 2025.08.30, 2025.09.04 YOCRUNCH VANILLA W/M&M 6OZ (UPC 46675000792) 2025.07.11, 2025.07.14, 2025.07.25, 2025.08.07, …

Distribution channels: Food & Beverage Industry
Published on July 15, 2025 - 10:44 GMT

World Market Recalls Emek Spread Pistachio Cacao Cream with Kadayif Due to Salmonella Contamination

Summary Company Announcement Date: July 14, 2025 FDA Publish Date: July 14, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Salmonella Company Name: World Market Brand Name: Product Description: …

Distribution channels: Food & Beverage Industry
Published on July 14, 2025 - 22:14 GMT

2025 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

May 22, 2025 The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On May 22, 2025, the committee will meet in open session to discuss and make recommendations on the selection of the 2025- …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 14, 2025 - 20:26 GMT

Jalux Americas, Inc. (dba J.sweets) Issues Allergy Alert on Undeclared Tree Nuts and Milk in L’espoir Brand Cookies

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry
Published on July 14, 2025 - 17:51 GMT

FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3

For Immediate Release: July 14, 2025 Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels consistent with …

Distribution channels: Food & Beverage Industry
Published on July 12, 2025 - 08:22 GMT

Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry

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