Federal record
FDA Warning Letter issued September 9, 2025 · As of October 2026, Vial did not find a close-out letter in FDA records. Read the FDA letter →
We're providing this information based on regulatory filings Vial reviewed as of 2026-10-07. Regulatory status can change, and actions may be resolved or closed out. Confirm current status with the issuing agency: FDA.gov →
Direct Meds
Reviewed by Vial Editorial · October 1, 2026
UT · Serves 48 states
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Direct Meds is a GLP-1 clinic available in 48 states. The FDA issued a warning letter involving Direct Meds on September 9, 2025, with no close-out letter found resolving it. Pricing starts at about $297 per month, though total cost should be confirmed before signing up.
What they offerWeight LossGLP-1
Why this score?
The Vial Score measures how much of this provider's public record Vial could confirm, and how clearly the provider discloses it. It does not measure quality of care.
| 85-100 | High Confidence |
| 70-84 | Well Documented |
| 50-69 | Limited Confidence |
| 0-49 | Flagged |
Direct Meds scores 38, in the Flagged band. The score moves when the public record changes. For Direct Meds, the item most likely to move it: LegitScript certification.
Payment never changes a score.
4 of 5 checks complete. The remaining checks have not been run yet. Missing checks reduce how complete the profile is. They are not a finding by themselves.
Score history
- 38September 2026Record updated
- 75August 2026Record updated
- 72July 2026Vial scoring update
- 75June 2026Record updated
- 46June 2026Record updated
- 64June 2026Vial scoring update
What we found on Direct Meds
We reviewed FDA enforcement records, OIG exclusions, DEA registration, and HIPAA breach records.
The FDA issued a warning letter involving Direct Meds on September 9, 2025. We have not found a close-out letter resolving it as of our last check (October 7, 2026); read the details below before going further. The company serves 48 states. We could not independently verify a third-party certification or accreditation as of October 2026.
Why this score: 4 of 5 checks complete. Each links to the public source it was verified against.
A check we haven’t completed yet is not a mark against this provider. It just means we’re still sourcing that record. The score reflects what we’ve confirmed so far, and updates as more checks come in.
Vial describes the record, not the provider. This is not a medical recommendation or endorsement. Last reviewed October 1, 2026.
Our take
Vial EditorialBased on the records and public materials we reviewed.
Direct Meds is a telehealth service selling compounded semaglutide and tirzepatide. Their offer pages list semaglutide shots at $297 a month, tirzepatide at $399 and under-the-tongue semaglutide at $249, the same at every dose. Their sales pages say there's no long-term commitment. Their terms describe auto-refill every 30 days that you must turn off 48 hours before the next charge. After the first 24 hours, an order generally can't be cancelled.
The FDA issued a warning letter to directmeds.com, Inc. dba DirectMeds on September 9, 2025. We found no close-out letter for it in FDA records checked on September 23, 2026. The letter is published at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/directmedscom-inc-dba-directmeds-716822-09092025. They don't name their pharmacies, medical groups or clinicians. They say they serve every state except Mississippi and Louisiana. Trustpilot reviewers give them 4.6 from 15,212 reviews, and the Better Business Bureau lists 258 complaints in three years.
What it costs
Direct Meds lists prices on its offer and solutions pages, not its homepage. Compounded semaglutide shots are $297 a month. Compounded tirzepatide is $399 a month. Sublingual semaglutide starts at $249 a month. The company states the price is the same at every dose. The fee covers medication, doctor visits, injection supplies and one-day shipping. The company states there are no membership fees. We saw no lab work listed. The offer page advertises $150 off at signup but does not explain which order it applies to. If it comes off the first month, a year of semaglutide is 12 charges of $297 minus $150, or $3,414. Without it, $3,564. Tirzepatide is 12 charges of $399, or $4,788, and $4,638 with the discount. Charges run every 30 days, so a 13th charge can land inside a calendar year. The company also mentions lower rates if you commit to 6 or 12 months. We could not confirm those prices. The terms say you can cancel up to 48 hours before the next charge by turning off auto-refill in your account. You have 24 hours to cancel an order. After that, it generally cannot be stopped, and medication already received is not refundable. Returned medication carries a $35 disposal fee. You get a full refund if the provider does not approve you. The company states it accepts HSA and FSA cards. It does not take insurance, according to a third-party review. Before paying, get in writing whether your plan auto-refills, the next charge date, and the total for any multi-month commitment.
Sources: directmeds.com · directmeds.com · directmeds.com · directmeds.com · glp1oracle.com · globenewswire.com · plexusdx.com
What patients report
On Trustpilot, Direct Meds shows 4.6 out of 5 from 15,212 reviews, seen September 21, 2026. About 84% are 5-star and 8% are 1-star. Trustpilot reports the company replies to about 98% of negative reviews, usually within two days. Praise centers on support staff who answer quickly and sort out account issues. The BBB profile, seen the same day, shows Direct Meds as not accredited and not rated. The BBB counts 258 complaints in three years and 230 closed in the last 12 months. The newest complaint we saw was dated July 4, 2026. The largest groups are product issues (91), service issues (70), billing (36) and delivery (25). Common themes are "cancel anytime" being hard to use in practice, multi-month shipments people did not expect, charges they dispute, orders that did not arrive, and refunds refused once medication had shipped. The pattern: day-to-day support gets good marks, and most 1-star stories trace back to the refill and refund rules. Those rules are in the terms, not on the sales page. We did not find a usable Reddit thread.
Sources: trustpilot.com · bbb.org · bbb.org
What the record means
Vial scores Direct Meds 38 out of 100, Flagged.
The FDA issued a warning letter to directmeds.com, Inc. dba DirectMeds on September 9, 2025. We found no close-out letter for it in FDA records checked on September 16, 2026. The letter is published at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/directmedscom-inc-dba-directmeds-716822-09092025. The company states it holds LegitScript certification and shows the seal on its site. That certification has not been checked against LegitScript's own lookup. The company states its medication is made by U.S. 503A compounding pharmacies, which its terms say may vary by location. No pharmacy partner is named, so you cannot look up who compounds the medication. No medical group or clinician is identified on the company's site. The company states it serves every state except Mississippi and Louisiana. States served have not been checked. Ask which pharmacy will fill your order and check its license with your state board before you pay.
Worth asking before you choose
Ask these before you sign up.
- 1What changed after the FDA warning letter?
- 2Has FDA issued a close-out letter?
- 3Are you operating as a 503A pharmacy or a 503B outsourcing facility?
- 4Which states are you licensed to ship to?
- 5Can you provide current state pharmacy license details?
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Screenshot these or show your doctor: they’re the same questions Vial would ask.
Compare record details
Advanced Medical Weight Loss has no federal action found; Direct Meds has an FDA warning letter with no close-out letter found.
Direct Meds scores 38, Advanced Medical Weight Loss scores 84.
Direct Meds is a telehealth platform; Advanced Medical Weight Loss is a clinic / medical practice.
Direct Meds serves 48 states; Advanced Medical Weight Loss serves 1 state.
| Direct Meds | Advanced Medical Weight Loss | |
|---|---|---|
| Federal actions | Confirmed | None found |
| Vial Score | 38/100 | 84/100 |
| LegitScript certified | No | No |
| States served | 48 states | 1 state |
| Provider type | Telehealth Platform | Clinic / Medical Practice |
What Vial measures, and what we don’t
We evaluate public records: federal enforcement history, registrations, certifications, and how transparent a provider is about its clinicians, pharmacies, and pricing. We don’t score bedside manner, clinical outcomes, or customer satisfaction, and we don’t collect user reviews.
Treatments offered
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Appears on: Tirzepatide Cost in 2026
Appears on: Semaglutide Cost in 2026
This page evaluates compliance signals, not clinical outcomes. Consult a licensed physician before starting any therapy, medication, or treatment. Vial does not provide medical advice.