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FDA warning letters, October 2025

Every warning letter FDA posted in October 2025: the company, the issuing office and the agency's own subject line, each linked to the letter.

Letters22
Issuing offices5

FDA posted 22 warning letters in October 2025. By issuing office: Center for Tobacco Products 9; Center for Drug Evaluation and Research (CDER) 7; Center for Devices and Radiological Health 4; Division of Northeast Imports 1; Division of West Coast Imports 1. Each row gives the agency's own subject line and links to the letter.

PostedLetter dateCompanyIssuing officeSubject (FDA's words)Letter
2025-10-282025-10-02Contec Medical Systems Co., Ltd.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2025-10-282025-10-03Qianjiang Kingphar Medical Material Co Ltd.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/MisbrandedRead the letter
2025-10-282025-10-23Quality Wholesale STL, LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2025-10-282025-09-09Royal PhilipsCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/MisbrandedRead the letter
2025-10-282025-10-24spacepuffbar.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2025-10-282025-10-16The Tranzonic Companies/Innocore Sales & Marketing Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2025-10-282025-10-09Turkana Food Inc.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)Read the letter
2025-10-282025-10-09V & L Produce, Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)Read the letter
2025-10-232025-10-23Kure CorporationCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2025-10-232025-10-23Kure Vaporium & LoungeCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2025-10-212025-10-10Acme United CorporationCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2025-10-212025-09-17BRS Analytical Services, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2025-10-212025-10-17electronicpuffs.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2025-10-212025-10-10Foshan Yiying Hygiene Products Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2025-10-212025-09-30Guangxi Yulin Pharmaceutical Group Co. Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2025-10-212025-07-18LEVO AGCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2025-10-212025-10-09Melcare Biomedical Pty LtdCenter for Drug Evaluation and Research (CDER)Nonprescription/OTCRead the letter
2025-10-212025-10-17vapesatl.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2025-10-212025-10-06www.usmedschoice.comCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2025-10-202025-10-16Ecig Charleston LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2025-10-202025-10-16GT Hyper Distribution, Inc.Center for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2025-10-202025-10-16Kure CBD & VapeCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter

Where this comes from

FDA publishes the warning letters it sends. Each row is one letter as the agency posted it: the company it is addressed to, the date on the letter, the date FDA posted it, the office that issued it and the agency's own subject line, with a link to the full letter. A warning letter states the agency's findings at the time it was written; it is not a final determination, and the company may have responded or since corrected the matter. Read the letter, and any response or close-out letter FDA has posted, before relying on it.

Cite this page

Permanent URL: https://mentionfox.com/fda/warning-letters/2025-10
Last updated 2026-10-18
FDA warning letters posted in October 2025: 22 letters. MentionFox, 2026-10-18. https://mentionfox.com/fda/warning-letters/2025-10