Federal record
FDA Warning Letter issued September 9, 2025 · As of September 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 2026-09-23. Regulatory status can change, and actions may be resolved or closed out. Confirm current status with the issuing agency: FDA.gov →
Hims & Hers
Reviewed by Vial Editorial · September 27, 2026
CA · Serves 50 states
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Hims & Hers is a GLP-1 clinic available in all 50 states. The FDA issued a warning letter involving Hims & Hers on September 9, 2025, with no close-out letter found resolving it. Pricing starts at about $149 per month, though total cost should be confirmed before signing up.
What they offerHair LossSexual Health
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 |
Hims & Hers scores 38, in the Flagged band. The score moves when the public record changes.
Payment never changes a score.
Score history
- 38September 2026Record updated
- 87July 2026Vial scoring update
- 89June 2026Record updated: pricing
- 86June 2026Record updated
- 87June 2026Record updated
- 85May 2026Record updated
What we found on Hims & Hers
We reviewed FDA enforcement records, OIG exclusions, DEA registration, HIPAA breach records, and LegitScript certification.
The FDA issued a warning letter involving Hims & Hers on September 9, 2025. We have not found a close-out letter resolving it as of our last check (September 23, 2026); read the details below before going further. The company serves all 50 states. We also confirmed LegitScript certification. Our findings reflect public records reviewed as of September 2026.
Why this score: 5 of 5 checks complete. Each links to the public source it was verified against.
Vial describes the record, not the provider. This is not a medical recommendation or endorsement. Last reviewed September 27, 2026.
Our take
Vial EditorialBased on the records and public materials we reviewed.
Hims & Hers is a telehealth company selling treatment online under two brands, Hims for men and Hers for women. For weight loss, a membership is required on top of medication: $39 the first month, then $149 a month. Medication starts at $149 a month for the Wegovy, Foundayo and Ozempic pills and $199 for the Wegovy pen and Ozempic. Subscriptions renew automatically, and partly used periods aren't refunded.
The FDA issued a warning letter to Hims & Hers Health, Inc. dba Hims 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/hims-hers-health-inc-dba-hims-716567-09092025. The FDA issued a warning letter to Hims & Hers Health, Inc. dba Hers 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/hims-hers-health-inc-dba-hers-716825-09092025. They are LegitScript certified and name six pharmacies in their terms. Hims & Hers names AnazaoHealth as a pharmacy that fills its prescriptions. The FDA issued a warning letter to AnazaoHealth Corporation on August 18, 2021, and we found no close-out letter in records checked on September 16, 2026. This does not change Hims & Hers's score, which reflects Hims & Hers's own records. On Trustpilot, Hims averages 2.9 from 9,295 reviews and Hers 3.3 from 10,263.
What it costs
Weight-loss medication is priced per month, and the membership comes on top. On the Hims weight-loss page, the Wegovy pill, the Wegovy pill microdosing plan, the Foundayo pill and the Ozempic pill each start at $149 a month; the Wegovy pen and Ozempic start at $199 a month; the Zepbound vial and the Zepbound KwikPen start at $299 a month; and Mounjaro and Zepbound pens are $1,899 a month. Hims states that these prices include medication only, if prescribed, and that an active Weight Loss Membership is required: $39 for the first month, then renewing automatically at $149 a month, billed separately and without a guaranteed prescription. Medication is not available without the membership. The medication fee is FSA and HSA eligible but the membership fee is not, and insurance is not required. The terms explain the rest. A subscription renews automatically unless you cancel at least two days before its renewal processing date, cancellation takes effect at the end of the current period, and Hims does not offer refunds for partially used subscription periods, though it may refund case by case at its discretion. Renewal charges and shipments may come up to two days early. Cancelling the Weight Loss Membership also stops any unshipped medication.
What patients report
The two brands have separate Trustpilot profiles and both lean negative. Hims shows 2.9 stars across 9,295 reviews, 38 percent five-star and 29 percent one-star; Hers shows 3.3 stars across 10,263 reviews, 38 percent five-star and 24 percent one-star; both had reviews posted the day we checked, September 16, 2026. The one-star reviews on Hims concentrate on billing and cancellation, with one reviewer describing a $149 membership they wanted to cancel and could not get refunded, and on deliveries that did not arrive where expected. Hers reviewers add price increases, with one describing a monthly price rising from $149 to $349. The Better Business Bureau file for Hims & Hers Inc. shows no letter grade, because the BBB says it lacks sufficient information to rate the business, alongside accreditation since February 22, 2018, 4,455 complaints closed in three years, 6,263 customer reviews, and the file opened January 29, 2018. Reddit was not sampled.
Sources: trustpilot.com · trustpilot.com · bbb.org
What the record means
Vial scores Hims & Hers 38 out of 100, Flagged.
We found no OIG or DEA actions and no HIPAA breach for Hims & Hers in records checked September 2026. Clinical leadership is publicly identified, including Dr. Craig Primack on the weight-loss page. LegitScript certification is confirmed. The FDA issued a warning letter to Hims & Hers Health, Inc. dba Hims 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/hims-hers-health-inc-dba-hims-716567-09092025. The FDA issued a warning letter to Hims & Hers Health, Inc. dba Hers 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/hims-hers-health-inc-dba-hers-716825-09092025. Hims & Hers names AnazaoHealth as a pharmacy that fills its prescriptions. The FDA issued a warning letter to AnazaoHealth Corporation on August 18, 2021, and we found no close-out letter in records checked on September 16, 2026. This does not change Hims & Hers's score, which reflects Hims & Hers's own records.
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?
See all 5 questionsShow fewer
Screenshot these or show your doctor: they’re the same questions Vial would ask.
Compare record details
REMEVi Health has no federal action found; Hims & Hers has an FDA warning letter with no close-out letter found.
Hims & Hers scores 38, REMEVi Health scores 86.
| Hims & Hers | REMEVi Health | |
|---|---|---|
| Federal actions | Confirmed | None found |
| Vial Score | 38/100 | 86/100 |
| LegitScript certified | Yes | Yes |
| States served | Nationwide (50 states) | Nationwide (50 states) |
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.
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Appears on: GLP-1 Telehealth Cost Comparison
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.