OVERLOOKED

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Class IIOngoing

Carolina Infusion, LLC recalls 16 products

Recall date · record updated Oct 14, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Carolina Infusion, LLC
Reason
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Nationwide within the U.S
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99867…

Products (16)

  1. TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;

    Codes/lots: Lots: 09012026@3, BUD: 10/16/2026; 08032026@16, BUD: 9/17/2026; 08052026@8, BUD: 9/19/2026; 08072026@13, BUD: 9/21/2026.Quantity: 5.6 mLs - in patient specific syringe dosesRecall no. D-0017-2027Class II

  2. SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: Lot: 08262026@6, BUD:10/10/2026.Quantity: 8 x 0.1 ml syringesRecall no. D-0018-2027Class II

  3. SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: Lot: 07282026@3, BUD: 9/11/2026; 08252026@9, BUD: 10/9/2026; 08042026@12, BUD: 9/18/2026; 08072026@15, BUD: 9/21/2026.Quantity: 57.0 mls - in patient specific syringe dosesRecall no. D-0019-2027Class II

  4. SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland

    Codes/lots: Lot: 07292026@12, BUD 09/12/2026; 07302026@7, BUD 09/13/2026.Quantity: 15 mls - in patient specific syringe dosesRecall no. D-0020-2027Class II

  5. QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: LOT: 08032026@24, BUD: 09/17/2026.Quantity: 5 mls in patient specific syringe dosesRecall no. D-0021-2027Class II

  6. 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, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,

    Codes/lots: Lot: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026.Quantity: 15 mLs - in patient specific syringe dosesRecall no. D-0022-2027Class II

  7. 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, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,

    Codes/lots: Lot: 07242026@7, BUD: 09/7/2026.Quantity: 5 mL in patient specific syringe dosesRecall no. D-0023-2027Class II

  8. 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, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: Lot:08042026@8, BUD: 9/18/2026.Quantity: 3 ML in patient specific syringe doseRecall no. D-0024-2027Class II

  9. 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, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: Lot:08062026@10, BUD: 9/20/2026.Quantity: 5 mL in patient specific syringe doseRecall no. D-0025-2027Class II

  10. SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .Quantity: 82.9 mls - in patient specific syringe doseRecall no. D-0026-2027Class II

  11. TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: Lot:07212026@18, BUD: 9/4/2026; 07222026@14, BUD: 9/5/2026; 07292026@8, BUD: 9/12/2026; 08052026@14, BUD: 9/19/2026; 08142026@1, BUD: 9/28/2026; 08192026@10, BUD: 10/3/2026; 08242026@25, BUD: 10/8/2026; 08282026@2, BUD: 10/12/2026; 08292026@1, BUD:10/13/2026;Quantity: 297 mL - in patient specific syringe doseRecall no. D-0027-2027Class II

  12. TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: Lot:07252026@3, BUD: 9/8/2026; 08112026@5, BUD: 9/25/2026; 08212026@21, BUD: 10/5/2026; 08282026@3, BUD: 10/12/2026.Quantity: 29.6 mls - in patient specific syringe doseRecall no. D-0028-2027Class II

  13. TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: Lot:08032026@23, BUD: 9/17/2026; 08172026@19, BUD: 10/1/2026; 08262026@13, BUD: 10/10/2026.Quantity: 24.8 mLs -in patient specific syringe doseRecall no. D-0029-2027Class II

  14. TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;

    Codes/lots: Lot:07212026@9, BUD: 9/4/2026; 07252026@2, BUD: 9/8/2026; 08122026@14, BUD: 9/26/2026; 08272026@8, BUD: 10/11/2026; 08312026@18, BUD: 10/15/2026.Quantity: 30.4 mLs - in patient specific syringe doseRecall no. D-0030-2027Class II

  15. 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, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: Lot: 07212026@1, BUD: 9/10/2026.Quantity: 10 ml -in patient specific syringe doseRecall no. D-0031-2027Class II

  16. Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Codes/lots: Lot: 07282026@2, BUD: 9/11/2026; 08032026@11, BUD: 9/17/2026; 08042026@3, BUD: 9/18/2026. .Quantity: 20 mLs - in patient specific syringe doseRecall no. D-0032-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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