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Compounding pharmacy profile

Empower Pharmacy: what the records show

Direct answer · checked October 14, 2026

As of October 14, 2026, Empower Pharmacy of Houston, Texas operates both a 503A compounding pharmacy (Empower Clinic Services, LLC dba Empower Pharmacy) and an FDA-registered 503B outsourcing facility (Empower Pharma). On September 18, 2026 the FDA issued warning letter 738238 to the 503A pharmacy, saying its tirzepatide/niacinamide and semaglutide/cyanocobalamin injections appeared to be "essentially copies" of approved drugs made in inordinate amounts and citing insanitary conditions. Two earlier warning letters were issued on April 2, 2025.

Empower at a glance

Legal nameEmpower Clinic Services, LLC dba Empower Pharmacy (503A); Empower Pharma (503B)
Location503A: 7601 N. Sam Houston Pkwy W., Houston, TX 77064 · 503B: 5980 W. Sam Houston Pkwy N., Houston, TX 77041
Type503A pharmacy and 503B outsourcing facility
On FDA 503B listYes — Empower Pharma, first registered July 16, 2016; last inspected November 14, 2025 (list updated September 30, 2026)
Accreditations it claimsPCAB (ACHC) for the 503A pharmacy; LegitScript — not independently verified
StatesSays it ships to all 50 states; the 503B facility says it cannot ship compounded products into California
GLP-1 products it listsSemaglutide/cyanocobalamin injection; tirzepatide/niacinamide injection
FDA actions 2024–2026Warning letters 738238 (Sept 18, 2026), 700964 and 700962 (April 2, 2025); Form 483s in 2023, 2024 and 2025
LitigationEli Lilly v. Empower (S.D. Texas, refiled July 25, 2025); part of the case was dismissed in 2026 and some claims proceed

Accreditation claims are the pharmacy's own; we could not check them against LegitScript's or ACHC's lookups, which were not publicly reachable. Every other row cites a source listed below.

What the FDA record shows

September 18, 2026 — warning letter 738238 (503A pharmacy). Following a November 3–14, 2025 inspection, the FDA named three products — tirzepatide/niacinamide 17/2 mg/mL and 8/2 mg/mL, and semaglutide/cyanocobalamin 5/0.5 mg/mL — and said they appeared to be "essentially copies of commercially available drug products regularly and in inordinate amounts." The letter also says prescriber "significant difference" statements appeared to be pre-selected options on third-party ordering platforms, and cites insanitary conditions. Empower had 15 working days to respond. Empower told CBS News it had "already remediated many of the issues outlined in the Warning Letter."

April 2, 2025 — two warning letters. Letter 700964 to the 503A pharmacy cited sterile drugs "prepared, packed, or held under insanitary conditions" (inspection September–October 2024). Letter 700962 to the 503B outsourcing facility cited repeated current-good-manufacturing-practice failures (inspection August 2024). Neither names a GLP-1 product.

Recall. Empower recalled pyridoxine HCl 100 mg/mL lot 609763 on September 5, 2024 for lack of sterility assurance, according to letter 700962.

What the letter means if your tirzepatide comes from Empower

A warning letter is not a recall and does not by itself stop shipments. It does mean the FDA considers the cited GLP-1 combinations unlawful to compound routinely. If your vial label says Empower, ask your prescriber whether your formulation is one of those named, whether a documented clinical reason supports it, and what the plan is if supply changes. Read our full analysis: FDA's Empower warning letter explained.

Who dispenses through Empower

Empower supplies many clinics and telehealth programs. IVIM Health lists Empower among its dispensing pharmacies and says your pharmacy may change from order to order. NexLife, our #1 pick, names Absolute Pharmacy, Premium Compounding and Boudreaux's New Drug Store for its standard plans.

How to verify this pharmacy yourself

Read the dispensing pharmacy's name on your vial label, then check its license with your state board of pharmacy, search the FDA outsourcing facility list if it claims 503B status, and scan the FDA's compounding inspections and actions page. Our 503A vs 503B guide explains the difference.

Want a program that names its pharmacies? NexLife, our #1 pick (94/100), lists Absolute Pharmacy, Premium Compounding and Boudreaux's New Drug Store on its plan page. $139/mo on a 12-month plan, same price at every dose.Compounded tirzepatide is not FDA-approved.
See NexLife plans →

Frequently asked questions

Is Empower Pharmacy FDA-approved?

No pharmacy is "FDA-approved," and compounded drugs are not FDA-approved. Empower Pharma is registered with the FDA as a 503B outsourcing facility, which subjects it to FDA inspection and good-manufacturing rules; the 503A pharmacy is overseen mainly by the Texas State Board of Pharmacy.

Did the FDA shut down Empower Pharmacy?

No. As of October 14, 2026 the FDA had issued warning letters, not a closure order, and we found no close-out letter for the September 18, 2026 letter.

Does Empower make compounded tirzepatide with niacinamide?

Yes. Empower lists tirzepatide/niacinamide injection, and the FDA named it in warning letter 738238 as appearing to be essentially a copy of an approved drug.

Sources

  1. FDA warning letter 738238, Sept 18, 2026
  2. FDA warning letter 700964, Apr 2, 2025
  3. FDA warning letter 700962, Apr 2, 2025
  4. FDA registered outsourcing facilities list
  5. FDA compounding inspections, recalls and other actions
  6. Empower: GLP-1 agonists page

Other pharmacy profiles: Hallandale Pharmacy · MediVera Compounding Pharmacy · Red Rock Pharmacy · Strive Pharmacy · Absolute Pharmacy · all pharmacies

Informational only. A pharmacy profile is not an endorsement. Compounded drugs are not FDA-approved.