Records · criterion S8

FDA warning letters named in this ledger

Recorded September 2026 · Standard v1.1

A warning letter alleges violations and asks for a written response. It does not halt a business, and it does not remove a seller from this ledger. 57 letters name 57 of the 586 companies recorded here, and all 57 still trade.

Each letter below has its own page, carrying the number, the addressee and address as the Food and Drug Administration files them, the website the agency states it reviewed, the statutory sections cited, what the letter alleges, the test that ties it to a ledger record, and what has happened since. Every letter is quoted from its own page on fda.gov. Criterion S8, enforcement status, records a letter on the seller record and fails a seller only where an action halted the business.

The count, with its denominator

Of the 586 records in the ledger, 57 disclose at least one letter and 529 disclose none. S8 records 0 failures across the 586 records, because no action recorded here has halted a business.

Every letter, by number

Grouped by the date the letter was issued, oldest group first. The subject is the one the FDA index files each letter under.

Letters to a pharmacy a record names

3 further letters are addressed to a compounding pharmacy rather than a seller. They are not counted above and change no disposition, and each is disclosed on every record that names the pharmacy under S3.

• 663403, September 2023, to Curexa – East, LLC dba Curexa (Compounding Pharmacy/Adulterated Drug Products). Named by 7 seller records.
• 694687, December 2024, to Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals (Compounding Pharmacy/Adulterated Drug Products). Named by 1 seller record.
• 738238, September 2026, to Empower Clinic Services, LLC dba Empower Pharmacy (CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug). Named by 7 seller records.

Two kinds of allegation

The index files the 57 letters under 4 subjects: 33 under “False & Misleading Claims/Misbranded (Telehealth)”; 17 under “Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)”; 6 under “Unapproved New Drugs/Misbranded”; 1 under “Unapproved New Drugs”. The subject line matters because two different statutes sit behind it. A telehealth letter cites sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act, which concern labeling and the advertising of a compounded drug. A research-vendor letter cites sections 505(a) and 301(d), which concern an unapproved new drug introduced into interstate commerce. A labeling citation and an unapproved-drug citation are different allegations against different conduct.

Two patterns recur in the telehealth letters. The first is a claim of sameness, that a compounded product carries the same active ingredient as an approved brand drug, which the agency reads as implying equivalence to an approved product. The second is a claim of authorship, that a pictured label names the seller as the compounder when a pharmacy the seller does not name did the compounding. Those letters close by asking the company to identify the entities that produce the products its website offers, which is the question criterion S3, pharmacy identification, asks of every record in the ledger.

What a letter does, and does not, do

Each letter requests a written response within fifteen working days and states that failure to address the violations may result in legal action, including seizure and injunction. Seizure and injunction are the actions S8 fails on. A letter is the notice that precedes them and it is not one of them. This site therefore records a letter in full on the seller record, links the seller exactly as it links a record with no letter, and reserves failure for an injunction, a consent decree, a seizure, or a closure.

17 of the letters above were issued on one day, in a wave the index records as 69 letters carrying that single issue date. The wave includes letters to Eli Lilly and Company and Novo Nordisk Inc., the manufacturers of the approved brand drugs those telehealth letters compare against.

The agency publishes a close-out letter where it has evaluated a company's corrective actions and found them adequate. As of September 2026 the index held 3,677 letters and 417 of them carried a close-out letter in that column, so an empty cell is a reading rather than a gap. 0 of the 57 letters recorded here carry one.

How the screen is run

The screen is run against the operating entity and the address, never against the brand name on the storefront. A letter is filed under the company, and a company may trade under names that appear nowhere in the letter, so a brand-name search returning nothing is not a clean result. Every attribution on these pages states its test, and a name resemblance is never the test.

An absence is reported only from a screen of the full index that also finds a known control letter, so a record with no letter reflects a real absence. The full procedure is on the method page.

The findings piece that censuses these letters across the whole ledger →

Sources

• FDA warning letter 663404 to Walgreens Boots Alliance, Inc.
• FDA warning letter 663246 to CVS Health
• FDA warning letter 695663 to Swisschems
• FDA warning letter 695156 to Prime Vitality, Inc. dba Prime Peptides
• FDA warning letter 694608 to Xcel Research LLC
• FDA warning letter 715218 to PureRawz
• FDA warning letter 716567 to Hims & Hers Health, Inc. dba Hims
• FDA warning letter 716825 to Hims & Hers Health, Inc. dba Hers
• FDA warning letter 716822 to the operating company of Direct Meds dba DirectMeds
• FDA warning letter 715879 to Sprout Health Partners LLC dba Sprout Health
• FDA warning letter 716501 to FitRX, LLC dba Zealthy
• FDA warning letter 716830 to Remedy Meds
• FDA warning letter 719811 to Elevate Your Wellness LLC, dba Elevated
• FDA warning letter 719809 to Healthon Inc. dba Healthon
• FDA warning letter 716508 to Bioverse, Inc. dba Bioverse
• FDA warning letter 716829 to Lovely Meds, Inc. dba Lovely Meds
• FDA warning letter 716510 to Lumimeds
• FDA warning letter 716502 to Tuyo Health, Inc. dba Tuyo Health
• FDA warning letter 716821 to Curex
• FDA warning letter 716458 to Intimate Rose
• FDA warning letter without a number to Lyfe Rx
• FDA warning letter 714755 to Matthew Stern, CEO MyStart Health LLC.
• FDA warning letter 716699 to TRYM Health, Inc. dba TRYM Health
• FDA warning letter 719337 to Pinnacle Professional Research dba Pinnacle Peptides
• FDA warning letter 721448 to Strut Health, LLC dba Strut
• FDA warning letter 721816 to Ivim Services LLC dba Ivim
• FDA warning letter 721449 to Good Girl LLC dba GoodGirlRX
• FDA warning letter 717989 to Lean Rx, Inc. dba SkinnyRx
• FDA warning letter 717991 to Kare Solutions, LLC dba Zappy
• FDA warning letter 721478 to Weightless Medical LLC dba WeightCare
• FDA warning letter 721450 to Kin Meds
• FDA warning letter 721814 to Alan Health Technologies Inc. dba Alan
• FDA warning letter 721795 to Belle Health LLC dba Belle
• FDA warning letter 721454 to Better Health Labs, Inc. dba Measured
• FDA warning letter 721451 to Genesis Health International Inc. dba Genesis
• FDA warning letter 721479 to Bliv Wellness LLC dba Bliv
• FDA warning letter 721481 to Aspen Aesthetics dba Fifty 410
• FDA warning letter 721453 to MaxLife Technologies Inc. dba Maxlife
• FDA warning letter 721474 to Premium Health Management Inc. dba Premium Health
• FDA warning letter 721475 to Refills Health, LLC dba Refills Health
• FDA warning letter 721472 to NewSelf Limited dba NewSelf
• FDA warning letter 717985 to Zeuss LLC dba Zeuss
• FDA warning letter 721455 to MEDVi, LLC dba MEDVi
• FDA warning letter 717987 to FitRX, LLC dba FitRx
• FDA warning letter 728279 to Eden Health International Inc. dba Eden
• FDA warning letter 728236 to Trinity HealthCare Supply, LLC dba altRx
• FDA warning letter 728291 to OrderlyMeds LLC dba OrderlyMeds
• FDA warning letter 730095 to Maximus Health, Inc. dba Maximus
• FDA warning letter 728283 to Joi and Blokes dba Joi + Blokes
• FDA warning letter 728280 to FITISH
• FDA warning letter 728287 to NativeMed LLC dba NativeMed
• FDA warning letter 728281 to Nexus Health Solutions LLC dba Harper Meds
• FDA warning letter 728293 to Roen Health, Inc. dba RoenRx
• FDA warning letter 730390 to Glow Medispa, LLC dba Mint Med
• FDA warning letter 730096 to Nexlife Inc. dba Nexlife
• FDA warning letter 728275 to FitRX, LLC dba AM RX
• FDA warning letter 728295 to VivioMD Group LLC dba VivioMD
• FDA, About Warning and Close-Out Letters
• FDA warning letter index

Counts are generated from the ledger at build time, against Standard v1.1, so this page cannot drift from the records it summarizes. It ranks nothing, recommends nothing, and carries no partner link.