Sermorelin Recall: Carolina Infusion Quad-Mix Injectable
FDA recall of Carolina Infusion, LLC QUAD-MIX Injectable due to lack of assurance of sterility related to formulation using bacteriostatic water and processing equipment used in the compounded product. The products were distributed nationwide in the U.S. in 15 mL total in patient-specific syringes; Lot numbers 07292026@12 (BUD 09/12/2026) and 07302026@7 (BUD 09/13/2026). Corrective action is not specified in the provided data.
| Brand | Carolina Infusion, LLC |
|---|---|
| Product | 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 |
| Reason | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. |
| Severity | moderate |
| Units affected | 5 |
| Distribution | Nationwide within the U.S |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any remaining QUAD-MIX injectable from these lots.
- Contact Carolina Infusion, LLC or your healthcare provider for disposal or replacement instructions using the lot numbers.
- Preserve the product and report any adverse effects to your clinician or the FDA recall hot line.
How to identify the recalled item
| Lot / date codes | Lot: 07292026@12, BUD 09/12/2026; 07302026@7, BUD 09/13/2026. |
|---|---|
| Lot / date codes | LOT: 08032026@24, BUD: 09/17/2026. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.