Carolina Infusion Recalls Quad-Mix Injectable Due to Sterility Risk
Carolina Infusion LLC recalls specific lots of Quad-Mix injectable due to lack of sterility assurance. Check lot numbers and consult your provider.
Stop using this now
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
What happened, in plain English
Carolina Infusion, LLC is recalling a compounded injectable product known as QUAD-MIX (containing papaverine, phentolamine, alprostadil, and tropicamide) because there is no assurance of sterility. This issue stems from the processing equipment used to create the product. The recall affects nationwide distribution within the U.S. Read more at govinfonow.com/recall/1622891-carolina-infusion-llc-recalls-quad-mix-papav-phento-alpros-trop.
Source Summary by GovInfoNow · govinfonow.com/recall/1622891-carolina-infusion-llc-recalls-quad-mix-papav-phento-alpros-trop · Updated October 21, 2026 · FDA enforcement record: FDA #D-0021-2027
Cite this page
“Carolina Infusion Recalls Quad-Mix Injectable Due to Sterility Risk.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1622891-carolina-infusion-llc-recalls-quad-mix-papav-phento-alpros-trop. Based on FDA recall #D-0021-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0021-2027%22&limit=1).
Why it’s dangerous
The primary hazard is a lack of assurance that the injectable solution is sterile. Using non-sterile injectables can introduce bacteria or other contaminants directly into the body, which poses a significant risk of infection or serious injury.
Who’s affected
Patients who have been prescribed this specific compounded injectable by a healthcare provider are affected. Because the product is packaged in single-use syringes dispensed based on specific patient prescriptions, only those with the exact lot and expiration date listed are at risk.
How to tell if you have this one
Check if you have QUAD-MIX (PAPAV/PHENTO/ALPROS/TROP) INJECTABLE packaged in single-use dosage syringes. Verify the lot number is 08032026@24 and the Best Use Date (BUD) is 09/17/2026.
- Brand
Carolina Infusion- Category
Drug
All 16 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide within the U.S
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0017-2027 | 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;; 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. | 5.6 mLs - in patient specific syringe doses |
| D-0018-2027 | SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936; Lot: 08262026@6, BUD:10/10/2026. | 8 x 0.1 ml syringes |
| D-0019-2027 | 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; 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. | 57.0 mls - in patient specific syringe doses |
| D-0020-2027 | 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; Lot: 07292026@12, BUD 09/12/2026; 07302026@7, BUD 09/13/2026. | 15 mls - in patient specific syringe doses |
| D-0021-2027 | 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; LOT: 08032026@24, BUD: 09/17/2026. | 5 mls in patient specific syringe doses |
| D-0022-2027 | 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,; Lot: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026. | 15 mLs - in patient specific syringe doses |
| D-0023-2027 | 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,; Lot: 07242026@7, BUD: 09/7/2026. | 5 mL in patient specific syringe doses |
| D-0024-2027 | 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; Lot:08042026@8, BUD: 9/18/2026. | 3 ML in patient specific syringe dose |
| D-0025-2027 | 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; Lot:08062026@10, BUD: 9/20/2026. | 5 mL in patient specific syringe dose |
| D-0026-2027 | 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; 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. . | 82.9 mls - in patient specific syringe dose |
| D-0027-2027 | 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; 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; | 297 mL - in patient specific syringe dose |
| D-0028-2027 | 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; 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. | 29.6 mls - in patient specific syringe dose |
| D-0029-2027 | 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; Lot:08032026@23, BUD: 9/17/2026; 08172026@19, BUD: 10/1/2026; 08262026@13, BUD: 10/10/2026. | 24.8 mLs -in patient specific syringe dose |
| D-0030-2027 | 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;; 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. | 30.4 mLs - in patient specific syringe dose |
| D-0031-2027 | 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; Lot: 07212026@1, BUD: 9/10/2026. | 10 ml -in patient specific syringe dose |
| D-0032-2027 | 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; Lot: 07282026@2, BUD: 9/11/2026; 08032026@11, BUD: 9/17/2026; 08042026@3, BUD: 9/18/2026. . | 20 mLs - in patient specific syringe dose |
What to do — step by step
Stop Using The Product
Do not use any syringes matching the recalled lot number due to sterility concerns.
Contact Your Provider
Reach out to your prescribing healthcare provider or pharmacist immediately for guidance on next steps and replacement medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product distributed?
The product was distributed nationwide within the United States.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0021-2027 (September 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0021-2027 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.