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FDA warning letters, August 2026

Every warning letter FDA posted in August 2026: the company, the issuing office and the agency's own subject line, each linked to the letter.

Letters24
Issuing offices7

FDA posted 24 warning letters in August 2026. By issuing office: Center for Drug Evaluation and Research (CDER) 12; Center for Veterinary Medicine 4; Office of Inspections and Investigations 2; Center for Tobacco Products 2; Center for Devices and Radiological Health 2; and others. Each row gives the agency's own subject line and links to the letter.

PostedLetter dateCompanyIssuing officeSubject (FDA's words)Letter
2026-08-252026-08-14R3 Medical CompaniesCenter for Biologics Evaluation and Research (CBER)Unapproved New Drugs/Unlicensed Biological Product ViolationsRead the letter
2026-08-252026-07-27Vargas Produce LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-08-182026-08-12Auriga Research Pvt. Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-08-182026-07-30DeJong Family Dairy, LLCCenter for Veterinary MedicineNew Animal Drug/AdulteratedRead the letter
2026-08-182026-08-13Eugia Pharma Specialities LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-08-182026-08-07giantnic.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-08-182026-08-12K.C. Pharmaceuticals, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-08-182026-08-07mikuvape.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-08-182026-07-24Nipro Renal Solutions USA, CorporationCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2026-08-182026-08-07Safrel Pharmaceuticals LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-08-182026-08-13Suretec Innovations, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated and MisbrandedRead the letter
2026-08-182026-08-06Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/MisbrandedRead the letter
2026-08-182026-07-06Waves and Wine, Inc.Center for Veterinary MedicineCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/AdulteratedRead the letter
2026-08-112026-07-31FairyGene, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedRead the letter
2026-08-112026-07-30Lico Industries, LLC., d.b.a. American Towelette CompanyCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-08-102026-06-16Tex-Stein DairyCenter for Veterinary MedicineNew Animal Drug/AdulteratedRead the letter
2026-08-042026-07-15AAL Trading Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-08-042026-07-23ABS CorporationCenter for Veterinary MedicineCGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-08-042026-07-24Dabur India LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-08-042026-07-14Friend’s Stable and Orchard, Inc.Human Foods ProgramFood/Prepared Packed or Held Under Insanitary Conditions/AdulteratedRead the letter
2026-08-042026-07-21Koven Technologies, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2026-08-042026-07-27Maria E. De La Torre Silva, M.D.Center for Drug Evaluation and Research (CDER)Clinical InvestigatorRead the letter
2026-08-042026-07-24Thomas Brunner Hygiene GmbHCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedRead the letter
2026-08-042026-07-27Woodbine Products Company Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead 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/2026-08
Last updated 2026-10-18
FDA warning letters posted in August 2026: 24 letters. MentionFox, 2026-10-18. https://mentionfox.com/fda/warning-letters/2026-08