U.S. Food and Drug Administration Press Releases - EIN Presswire

Published on November 11, 2025 - 23:09 GMT

Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research

For Immediate Release: November 11, 2025 The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced that Richard Pazdur, M.D., has been appointed director of the Center for Drug Evaluation and …

Distribution channels: Food & Beverage Industry

Published on November 11, 2025 - 21:14 GMT

ByHeart Broadens Voluntary Recall While Investigation Continues

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 November 11, 2025 - 14:37 GMT

IBSPOT.com Inc. - 715657 - 10/27/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Danielle White Recipient Title President IBSPOT.com Inc. 1414 Willow Avenue Elkins Park, PA 19027 United States support@ibspot.com Issuing Office: Center for Drug Evaluation and Research ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 11, 2025 - 14:37 GMT

Miers Laboratories, Ltd - 715378 - 11/03/2025

Delivery Method: VIA Electronic Mail Reference #: 320-26-13 Product: Drugs Recipient: Recipient Name Mr. Andrew Criglington Recipient Title Chief Executive Officer Miers Laboratories, Ltd 32 Waiu Street, Wainuiomata Lower Hutt Wellington 5014 New Zealand …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 11, 2025 - 14:37 GMT

Taizhou Kangping Medical Science and Technology Co., Ltd. - 711081 - 10/09/2025

Delivery Method: Via Email Reference #: 320-26-01 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Yuegen Wang Recipient Title General Manager Taizhou Kangping Medical Science and Technology Co., Ltd. Building 3, No 27 Tai’an Road …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 1, 2025 - 08:17 GMT

FDA Acts to Protect Children from Unapproved Fluoride Drug Products

For Immediate Release: October 31, 2025 The U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. The FDA sent notices to four companies outlining the …

Distribution channels: Food & Beverage Industry

Published on October 31, 2025 - 20:18 GMT

Vanguard Enterprises, LLC. dba Bedrock MFG Recalls Monarch Premium Kratom Powder Because of Possible Health Risk

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 October 31, 2025 - 17:54 GMT

Ingestible Fluoride Drug Products

FDA recommends that ingestible fluoride drug products be limited to children aged three years and older who are at high risk for tooth decay. Read FDA's assessment of the benefit/risk considerations regarding the use of ingestible fluoride drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 30, 2025 - 21:17 GMT

Moonlight Companies Voluntarily Recalls California-Grown Conventional Yellow and White Peaches Because of Possible Health Risk

Moonlight Yellow Peaches Individual pieces 4401 4044 P1 01PCLC, 03PCAF, 106PCLF, 113PCAF, 113PCLF, 129PCLF, 134PCLF, 142PCLF, 150PCLF, 151PCLF, 159PCABA, 159PCABB, 159PCPG10, 20, 22PCAB, 22PCPG10A, 22PCPG10B, 22PCP8A, 22PCPG8B, 22PCPG8C, 23, 25, 30PCEN …

Distribution channels: Food & Beverage Industry

Published on October 29, 2025 - 22:49 GMT

FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs

For Immediate Release: October 29, 2025 The U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologic drugs that …

Distribution channels: Food & Beverage Industry

Published on October 29, 2025 - 20:46 GMT

New Hoque & Sons Inc Issues Alert on Uneviscerated “Dry Ghoinnya Fish”

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 October 29, 2025 - 16:24 GMT

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need ...

Docket Number: FDA-2011-D-0605 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of New Drugs, Office of Therapeutic Biologics and Biosimilars FDA is posting this document to provide advance notice to the public. After the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 29, 2025 - 13:03 GMT

CANCELED - 17th Annual Sentinel Initiative Public Workshop - 11/06/2025

On This Page Date: November 6, 2025 Time: 9:00 a.m. - 3:00 p.m. ET Location: Event Location FDA Headquarters FDA White Oak Campus 10903 New Hampshire Ave, Building 31 The Great Room Silver Spring, MD 20903 United States The 17th Annual Sentinel Initiative …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 29, 2025 - 02:38 GMT

Homeneeds Inc. Recalls Devi Brand Ground Cinnamon (Dalchini Powder) Because of Possible Health Risk

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 October 29, 2025 - 02:38 GMT

Pacific International Marketing Recalls Fresh Italian Parsley Because of Possible Health Risk

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 October 29, 2025 - 00:16 GMT

POSTPONED - 17th Annual Sentinel Initiative Public Workshop - 11/06/2025

On This Page Date: November 6, 2025 Time: 9:00 a.m. - 3:00 p.m. ET Location: Event Location FDA Headquarters FDA White Oak Campus 10903 New Hampshire Ave, Building 31 The Great Room Silver Spring, MD 20903 United States The 17th Annual Sentinel Initiative …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 28, 2025 - 20:42 GMT

Purity Products Announces Recall on the Dietary Supplement, My Bladder Because of Possible Health Risk

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 October 28, 2025 - 14:47 GMT

The Tranzonic Companies/Innocore Sales & Marketing Inc. - 712258 - 10/16/2025

Delivery Method: Via Electronic Mail - Delivery and Read Receipt Requested Reference #: 320-26-07 Product: Drugs Recipient: Recipient Name Mr. Robert Kibbe Recipient Title President and CEO The Tranzonic Companies/Innocore Sales & Marketing Inc. 26301 …

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Published on October 27, 2025 - 18:45 GMT

Peterson Company Recalls Twin Sisters Creamery Brand Whatcom Blue and Farmhouse Cheese Products Because of Possible Health Risk

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 October 25, 2025 - 04:00 GMT

E.A. Sween Company Announces Product Recall Due to Choking Hazard

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