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Ongoing FDAEvent 99867 (7 days ago)

Carolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables

Carolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables lack 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

Carolina Infusion, LLC is recalling Tirzepatide, Semaglutide, Tri-Mix, Quad-Mix, Sermorelin Acetate, and Tirzepatide/Cyanocobalamin injectables due to lack of assurance of sterility.

For Tri-MIX (PAPAV/PHENTO/ALPROS) 30/2/20, Tirzepatide/Cyanocobalamin 64/2 MG/ML, Tri-MIX (PAPAV/PHENTO/ALPROS) 30/2/40, Semaglutide/Cyanocobalamin 3/2 MG/ML, and Semaglutide/Cyanocobalamin 9/2 MG/ML, the reason includes related to formulation using bacteriostic water and related to processing equipment used in compounded product.

For other products, the reason is related to processing equipment used in compounded product. The recall began September 10, 2026, and was added to the FDA's Enforcement Report on October 8, 2026.

Summary by Recall Canary from the FDA notice.

More sterility failure recalls

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 your mix affected?

Match your product and all the details in one listed combination.

  1. Tri-MIX (PAPAV/Phento/Alpros),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription

    Reason: Lack of assurance of sterility related to formulation using bacteriostic water; related to processing equipment used in compounded product.

    Lot
    • 07212026

  2. Tri-MIX (PAPAV/Phento/Alpros),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription

    Reason: Lack of assurance of sterility related to processing equipment used in compounded product.

    Lot
    • 07242026

  3. Tri-MIX (PAPAV/Phento/Alpros),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription

    Reason: Lack of assurance of sterility related to processing equipment used in compounded product.

    Lot
    • 08062026

  4. Tirzepatide/Cyanocobalamin

    Reason: Lack of assurance of sterility related to formulation using bacteriostic water; related to processing equipment used in compounded product.

    1. Strength
      64/2 mg/mL
      Lot
      • 07252026
    2. Strength
      76/2 mg/mL
      Lot
      • 08032026
    3. Strength
      85/2 mg/mL
      Lot
      • 07212026
    4. Strength
      26/2 mg/mL
      Lot
      • 07212026

  5. Tri-MIX (PAPAV/Phento/Alpros),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription

    Reason: Lack of assurance of sterility related to formulation using bacteriostic water; related to processing equipment used in compounded product.

    Lot
    • 07282026

  6. QUAD-MIX( PAPAV/Phento/Alpros/TROP) Injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription

    Reason: Lack of assurance of sterility related to processing equipment used in compounded product.

    Lot
    • 08032026

  7. Semaglutide/Cyanocobalamin

    Reason: Lack of assurance of sterility related to formulation using bacteriostic water; related to processing equipment used in compounded product.

    1. Strength
      3/2 mg/mL
      Lot
      • 07282026
    2. Strength
      9/2 mg/mL
      Lot
      • 07242026

  8. Tirzepatide

    Reason: Lack of assurance of sterility related to formulation using bacteriostic water; related to processing equipment used in compounded product.

    Strength
    26 mg/mL
    Lot
    • 09012026

  9. Tri-MIX (PAPAV/Phento/Alpros), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription

    Reason: Lack of assurance of sterility related to processing equipment used in compounded product.

    Lot
    • 08042026

  10. Semaglutide

    Reason: Lack of assurance of sterility related to formulation using bacteriostic water; related to processing equipment used in compounded product.

    Strength
    3 mg/mL
    Lot
    • 08262026

  11. Sermorelin Acetate

    Reason: Lack of assurance of sterility related to formulation using bacteriostic water; related to processing equipment used in compounded product.

    Strength
    1 mg/mL
    Lot
    • 07292026

  12. Tri-MIX (PAPAV/Phento/Alpros),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription

    Reason: Lack of assurance of sterility related to processing equipment used in compounded product.

    Lot
    • 08072026

Details

Company began the recall
Event ID
99867
Company
Carolina Infusion, LLC
Hazard
Sterility failure

  1. Company began the recall

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

  3. Listed on Recall Canary

  4. Summary updated

  5. In FDA's weekly enforcement report

Other sterility failure recalls

See all

Summary by Recall Canary, written with AI · summary updated Oct 10, 2026 · primary source: U.S. Food and Drug Administration