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FDA warning letters on compounded GLP-1s

151 letters to the companies selling, compounding or supplying copies of semaglutide and tirzepatide, pulled from fda.gov and linked to the original of each. Where the company is one we rank, the letter sits on its page here and caps its score — because enforcement history is worth something at the moment you are choosing a provider, not filed in a database you would have to know to search. The 5 letters to the makers of the approved drugs themselves are listed apart, at the end.

Last pulled from fda.gov 2026-09-29. A letter is matched to a seller we rank by a person, not automatically.

What the FDA actually objects to

Two complaints account for 110 of the 151. One is that a company sold a drug the FDA has not approved; the other is that it said things about the drug that were not true. Neither is about the medicine being dangerous, and both are about the seller — which is why a letter here sits on the page of the company it names rather than on the drug's page.

  • 20232 letters issued
  • 202410 letters issued
  • 202568 letters issued
  • 202671 letters issued
    year still running
letters issued
Warning letters by the year the FDA issued them. 2026 is not finished, so its bar is a floor rather than a total.
What the letter says the company didLetters
False & Misleading Claims/Misbranded (Telehealth)55
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)55
Unapproved New Drugs/Misbranded12
Compounding Pharmacy/Adulterated Drug Products8
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet5
Unapproved New Drugs Sold Over the Internet4
CGMP/Finished Pharmaceuticals/Adulterated2
Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet2
Finished Pharmaceuticals/Unapproved New Drug/Misbranded2
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug1
CGMP/API/Adulterated and Misbranded Drugs1
CGMP/Adulterated and Unapproved New Drug/Misbranded1
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded1
Unapproved New Drug/Misbranded1
Finished Pharmaceutical/Unapproved New Drug/Adulterated/Misbranded1

The dates say when the regulator started paying attention: 10 letters in 2024, 68 in 2025, 71 in 2026 so far. That is roughly 7 times as many in a single year, and it is the reason a seller's record matters more now than the same record would have two years ago.

Companies we rank (5, 6 letters)

  • 2026-06-08Eden4.5

    False & Misleading Claims/Misbranded (Telehealth)

    … offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, your website’s … or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the … Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section …

    Read the letter on fda.gov →
  • 2026-02-20Medvi4.5

    False & Misleading Claims/Misbranded (Telehealth)

    … offers compounded drug products, including semaglutide and tirzepatide drug products. 1 As described below, your … or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the … in any particular. The compounded semaglutide and tirzepatide products displayed on your website identify …

    Read the letter on fda.gov →
  • 2026-02-20Strut Health4.5

    False & Misleading Claims/Misbranded (Telehealth)

    … offers compounded drug products, including semaglutide and tirzepatide drug products. 1 As described below, your … or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the … in any particular. The compounded semaglutide and tirzepatide products displayed on your website identify …

    Read the letter on fda.gov →
  • 2025-09-09Hims & Hers4.5

    Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

    … website offers various compounded drug products, including semaglutide . As described below, your claims concerning your compounded semaglutide products are false or misleading under sections … The following claims concerning your compounded semaglutide products appear on your website: • “Same active …

    Read the letter on fda.gov →
  • 2025-09-09Hims & Hers4.5

    Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

    … 2025 and has observed that your website offers various compounded drug products, including semaglutide. As … products appear on your website: • “Weekly injectable GLP - 1 with the same active ingredient as Ozempic and Wegovy” • …

    Read the letter on fda.gov →
  • 2025-09-09Zealthy4.1

    Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

    … 2025 and has observed that your website offers various compounded drug products, including semaglutide. As … healthcare provider will help you find the right dose of GLP - 1 Medication including Semaglutide (same active ingredient as …

    Read the letter on fda.gov →

Every letter we found

IssuedCompanyCited forOn halfrx
2026-09-18Empower Clinic Services, LLC dba Empower PharmacyCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drugnot ranked
2026-08-24Peak Performance PeptidesUnapproved New Drugs/Misbrandednot ranked
2026-08-24Royal Peptides LLCUnapproved New Drugs/Misbrandednot ranked
2026-08-24NuScience Peptides LLCUnapproved New Drugs/Misbrandednot ranked
2026-08-24Peptide Partners LLCUnapproved New Drugs/Misbrandednot ranked
2026-08-24TXP Innovations LLC dba Tex PeptidesUnapproved New Drugs/Misbrandednot ranked
2026-06-08Glow Medispa, LLC dba Mint MedFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08NativeMed LLC dba NativeMedFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Eden Health International Inc. dba EdenFalse & Misleading Claims/Misbranded (Telehealth)Eden
2026-06-08D&H Medical ServicesFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Clover Meds LLC dba Clover MedsFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Maximus Health, Inc. dba MaximusFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Nexus Health Solutions LLC dba Harper MedsFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Momentum Health 360 dba Momentum HealthFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Nova Vascular LLC dba NOVARXFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Joi and Blokes dba Joi + BlokesFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Roen Health, Inc. dba RoenRxFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08OrderlyMeds LLC dba OrderlyMedsFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08FITISHFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Ready MedFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Ezra Holdco LLC dba EzraFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Medica Weight LossFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08HydraMed IV LLC dba HydraMedFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08FitRX, LLC dba AM RXFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Public Health Solution LLC dba DrMedHealthFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Nexlife Inc. dba NexlifeFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Altru Telehealth, LLC dba Altru TelehealthFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Trinity HealthCare Supply, LLC dba altRxFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Amie Health, Inc. dba AmieFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08Thrivelab Co. dba ThrivelabFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-06-08VivioMD Group LLC dba VivioMDFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-05-01Harbin Jixianglong Biotech Co., Ltd.CGMP/API/Adulterated and Misbranded Drugsnot ranked
2026-04-14New Life Pharma LLCCGMP/Adulterated and Unapproved New Drug/Misbrandednot ranked
2026-04-07ProRx LLCCompounding Pharmacy/Adulterated Drug Productsnot ranked
2026-03-31Mile High Compounds LLCUnapproved New Drugs Sold Over the Internetnot ranked
2026-03-31Lovega LLC dba Pink Pony PeptidesUnapproved New Drugs Sold Over the Internetnot ranked
2026-03-31Gram PeptidesUnapproved New Drugs Sold Over the Internetnot ranked
2026-03-31Prime SciencesUnapproved New Drugs Sold Over the Internetnot ranked
2026-02-20MEDVi, LLC dba MEDViFalse & Misleading Claims/Misbranded (Telehealth)Medvi
2026-02-20Lean Rx, Inc. dba SkinnyRxFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Levity Inc. dba LevityFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Kin MedsFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Good Girl LLC dba GoodGirlRXFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20PharmaZeeFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Peaks Curative, LLC dba PeaksFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Viv Health, Inc. dba VIV RXFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Weightless Medical LLC dba WeightCareFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Refills Health, LLC dba Refills HealthFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Kare Solutions, LLC dba ZappyFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Zeuss LLC dba ZeussFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Deluxe IV Aesthetics PLLC dba Deluxe IV and AestheticsFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Ivim Services LLC dba IvimFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Strut Health, LLC dba StrutFalse & Misleading Claims/Misbranded (Telehealth)Strut Health
2026-02-20Genesis Health International Inc. dba GenesisFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Newman Clinic, PLLC dba Newman ClinicFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20FitRX, LLC dba FitRxFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20MaxLife Technologies Inc. dba MaxlifeFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Aspen Aesthetics dba Fifty 410False & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20BluefitMDFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Bliv Wellness LLC dba BlivFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Belle Health LLC dba BelleFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Dripgym Mobile Parent, LLC dba Amp HealthFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Alan Health Technologies Inc. dba AlanFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-2024HrDoc, Inc. dba 24HrDocFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20NewSelf Limited dba NewSelfFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Premium Health Management Inc. dba Premium HealthFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Better Health Labs, Inc. dba MeasuredFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-20Join JosieFalse & Misleading Claims/Misbranded (Telehealth)not ranked
2026-02-09Thrive Health and Wellness, LLC dba Thrive Health SolutionsCompounding Pharmacy/Adulterated Drug Productsnot ranked
2026-01-20GenoGenix LLCCompounding Pharmacy/Adulterated Drug Productsnot ranked
2026-01-16Boothwyn Pharmacy, LLCCompounding Pharmacy/Adulterated Drug Productsnot ranked
2025-12-08Darmerica, LLCCGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbrandednot ranked
2025-12-01Apothecary Pharma, LLCCompounding Pharmacy/Adulterated Drug Productsnot ranked
2025-10-10PQ Pharmacy, LLCCompounding Pharmacy/Adulterated Drug Productsnot ranked
2025-09-11Chengdu Brilliant Biopharmaceutical Co., Ltd.CGMP/Finished Pharmaceuticals/Adulteratednot ranked
2025-09-10motionpharmacy.comUnapproved New Drug/Misbrandednot ranked
2025-09-09Hims & Hers Health, Inc. dba HimsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)Hims & Hers
2025-09-09ASN-LABSUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Body Good StudioUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Canada Med StopUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09All American WellnessUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Intimate RoseUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Invigorate Med SpaUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09MedClub by Dr. JennUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Remedy MedsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09EA WORKS Limited Liability Company dba Trust LabsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Fancy Meds, LLC dba Fancy MedsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Matthew Stern, CEO MyStart Health LLC.Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Elite Health CenterUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Healthon Inc. dba HealthonUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09eDrugstoreUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Healthy MaleUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Dr. Gater’s Weight Loss & WellnessUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Try NovaUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Lean Dreams LLC dba LeanDreamsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Hims & Hers Health, Inc. dba HersUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)Hims & Hers
2025-09-09FitRX, LLC dba ZealthyUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)Zealthy
2025-09-09EvoLife WellnessUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Get.Fit.Medical, LLC dba Get.Fit.MedicalUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09FWD Care, Inc. dba FWDUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Mane & Steel, LLC. dba Mane & SteelUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Nuvo Life Health Inc. dba Nuvo Life HealthUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09directmeds.com, Inc. dba DirectMedsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Expert AestheticsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Healthy Living ClinicUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Amazing MedsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09GenLabMedsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09ybycmedsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09iVisitDoc, Inc. dba iVisitDocUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09TRYM Health, Inc. dba TRYM HealthUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09The HCG InstituteUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Vitals RXUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Tuyo Health, Inc. dba Tuyo HealthUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Las Villas Health Care LLC dba Villas HealthUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Lyfe RxUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09JulyMDUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09SlendidUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Sprout Health Partners LLC dba Sprout HealthUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Master Pharmaceuticals GroupUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Lovely Meds, Inc. dba Lovely MedsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Reset IV, LLC dba Reset IVUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09inspire.clinicUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Bioverse, Inc. dba BioverseUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09SimpleRxUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Elevate Your Wellness LLC, dba ElevatedUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09Cosmo Medical Spa dba Cosmo Med SpaUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09SemaBioUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09CurexUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09HealBerryUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09LumimedsUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-09-09GLP-1 SolutionUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)not ranked
2025-07-29cheaptrustedpharmacy.comNotice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internetnot ranked
2025-06-12www.buynetmeds.comUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internetnot ranked
2025-05-05www.peacefulmeds.comUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internetnot ranked
2025-04-23www.24hreup.bizNotice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internetnot ranked
2025-04-08Tailstorm Health Inc. dba Medivant HealthCompounding Pharmacy/Adulterated Drug Productsnot ranked
2025-03-04ProRx, LLCCompounding Pharmacy/Adulterated Drug Productsnot ranked
2025-02-26USApeptide.comUnapproved New Drugs/Misbrandednot ranked
2025-01-13www.weightcrunchshop.comUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internetnot ranked
2024-12-10Summit Research PeptidesUnapproved New Drugs/Misbrandednot ranked
2024-12-10Xcel Research LLCUnapproved New Drugs/Misbrandednot ranked
2024-12-10SwisschemsUnapproved New Drugs/Misbrandednot ranked
2024-12-10Prime Vitality, Inc. dba Prime PeptidesUnapproved New Drugs/Misbrandednot ranked
2024-09-12Nomida.bizUnapproved New Drugs/Misbrandednot ranked
2024-08-20AnuMed International, LLCFinished Pharmaceutical/Unapproved New Drug/Adulterated/Misbrandednot ranked
2024-06-24Ozempen.comUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internetnot ranked
2024-04-24www.dashpct.comUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internetnot ranked
2024-02-07US Chem LabsCGMP/Finished Pharmaceuticals/Adulteratednot ranked
2024-02-07Synthetix Inc. DBA Helix Chemical SupplyUnapproved New Drugs/Misbrandednot ranked
2023-10-02www.gorillahealing.comFinished Pharmaceuticals/Unapproved New Drug/Misbrandednot ranked
2023-10-02www.semaspace.comFinished Pharmaceuticals/Unapproved New Drug/Misbrandednot ranked

Letters to the drug makers themselves (5)

These concern the makers' own approved products — how they were promoted, and in one case how adverse events were reported — rather than compounded copies, so they are not counted in anything above.

What these letters mean

What is an FDA warning letter?
It is how the FDA tells a company it considers a product, practice or marketing claim to be in violation of the Federal Food, Drug, and Cosmetic Act. It is a public document published on fda.gov. It is not a court finding, not a fine, and not proof that anyone was harmed — it is the agency putting an objection on the record and asking for a response.
Does a warning letter mean I should not use that company?
Not on its own. Read what was cited: a letter about marketing claims is a different thing from one about how a drug was made. What it does mean is that a regulator has an open objection, which belongs in front of you while you are choosing rather than in a database you would never think to search.
Why do some letters here have no seller page next to them?
Because we do not rank that company. We publish the letter anyway — an FDA objection to a firm selling compounded GLP-1s is worth seeing whether or not it is on our list, and a comparison site that only showed enforcement against companies it happens to cover would be telling you something misleading by omission.
How is this connected to the halfrx score?
A confirmed letter against a company we rank goes on that company's page here and caps its score at 4.5 out of 10, the same treatment as an open FTC or state action. Matches are checked by a person before publication, because attributing a regulator's letter to the wrong company is a serious thing to get wrong.
Something on this page wrong? Tell us

Please leave out anything about your own health. How a report is handled: privacy.