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FDA warning letters, February 2026

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

Letters37
Issuing offices10

FDA posted 37 warning letters in February 2026. By issuing office: Center for Drug Evaluation and Research (CDER) 12; Center for Tobacco Products 6; Center for Devices and Radiological Health 5; Human Foods Program 5; Center for Biologics Evaluation and Research (CBER) 3; and others. Each row gives the agency's own subject line and links to the letter.

PostedLetter dateCompanyIssuing officeSubject (FDA's words)Letter
2026-02-242026-02-12AQ USA Inc., d.b.a Ross Healthcare Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-02-242026-01-28Beta Bionics, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2026-02-242026-02-11Dynamic Stem Cell TherapyCenter for Biologics Evaluation and ResearchUnapproved New Drugs/Unlicensed Biological Product ViolationsRead the letter
2026-02-242026-01-16East CK Trading Inc.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)Read the letter
2026-02-242026-02-06ExThera Medical CorporationCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA)Read the letter
2026-02-242025-12-12MedisourceRxCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug ProductsRead the letter
2026-02-242026-02-12A. Nelson & Co. Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-02-242026-02-13The Sabagh Group Inc/lighterusa.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-02-242026-02-13swedishproducts.onlineCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-02-242026-01-22Tombak LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-02-172026-02-02Bertrand P. Cole, D.O.Center for Drug Evaluation and Research (CDER)Clinical InvestigatorRead the letter
2026-02-172026-02-06Cosmetic Manufacturers Pty Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-02-172026-01-08Elanco Animal Health USACenter for Veterinary MedicineFalse & Misleading Claims/MisbrandedRead the letter
2026-02-172026-01-29Fidelity Melon, IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-02-102026-02-05Beach Weekend Management LLC dba Nic and Jet FuelCenter for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-02-102026-02-05Bio-Medical Pharmaceutical Manufacturing CorporationCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-02-102025-12-11BNC Distribution Inc.Center for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-02-102026-01-16Boothwyn Pharmacy, LLCCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug ProductsRead the letter
2026-02-102026-01-29Central Coast Multispecialty Medical Group, Inc.Center for Biologics Evaluation and Research (CBER)Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Read the letter
2026-02-102026-01-27Conceive Fertility CenterCenter for Biologics Evaluation and Research (CBER)Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Read the letter
2026-02-102026-01-23Louisville Reproductive CenterCenter for Biologics Evaluation and ResearchDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Read the letter
2026-02-102026-02-02Mark S. Dacey, M.D.Center for Drug Evaluation and Research (CDER)Clinical InvestigatorRead the letter
2026-02-102025-12-10Maui Seafood LLCHuman Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsRead the letter
2026-02-102026-01-30niqpouches.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-02-102026-02-10ProDx HealthCenter for Biologics Evaluation and Research (CBER)Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)Read the letter
2026-02-102026-01-21Signature Formulations, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-02-032026-01-23Abbott Diabetes Care, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2026-02-032025-08-21Carolina Seafood Inc.Human Foods ProgramSeafood HACCP/CGMP for Foods/AdulteratedRead the letter
2026-02-032026-01-09CC Pollen CompanyHuman Foods ProgramCGMP/Dietary Supplement/Adulterated/MisbrandedRead the letter
2026-02-032026-01-09Christopher Dale ButlerHuman Foods ProgramAcidified Foods/Emergency Permit Control/AdulteratedRead the letter
2026-02-032026-01-30Cohance Lifesciences LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-02-032025-09-10Eniva USA, Inc.Human Foods ProgramCGMP/Dietary Supplement/Adulterated/MisbrandedRead the letter
2026-02-032026-01-27Flextronics America LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2026-02-032026-01-30gotpouches.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-02-032026-01-15The Great Smart African Food LLCDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)Read the letter
2026-02-032026-01-27HTO Nevada, Inc. dba KirkmanCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-02-032026-01-08Unomedical Device S.A. de C.V.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/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/2026-02
Last updated 2026-10-18
FDA warning letters posted in February 2026: 37 letters. MentionFox, 2026-10-18. https://mentionfox.com/fda/warning-letters/2026-02