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Ongoing FDAEvent 99990 (2 days ago)

Houston Rx Sermorelin and Tirzepatide/Niacinamide Injections

Sermorelin sterile injectable solution lacks process control, and Tirzepatide/Niacinamide injection lacks assurance of sterility.

Moderate risk

Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Houston Rx LLC recalled Sermorelin sterile injectable solution and Tirzepatide/Niacinamide injection. The Sermorelin lacks process control, and the Tirzepatide/Niacinamide lacks assurance of sterility. The recall began September 25, 2026, and was added to the FDA's Enforcement Report on October 13, 2026.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:

  1. Check the FDA or company notice for instructions specific to this product.
  2. Ask your pharmacist or doctor whether your lot is affected and what to do.

Is yours affected?

2 products

Affected if its lot code is listed.

  1. Tirzepatide/Niacinamide 2mL vial (

    Reason: Lack of assurance of sterility.

    Strength
    40 mg
    Lot
    • TZN-080326-20
    • 2-2
  2. Sermorelin

    Reason: Lack of process control

    Strength
    1 mg/mL
    Lot
    • SER-081726-1-10

Details

Company began the recall
Event ID
99990
Company
Houston Rx LLC
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

Summary by Recall Canary, written with AI · summary updated Oct 14, 2026 · primary source: U.S. Food and Drug Administration