FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion semaglutide injectable recalled for sterility assurance concerns
What this means
Carolina Infusion LLC is recalling semaglutide 3 mg/mL injectable syringes due to concerns about sterility assurance. The issue stems from the formulation process using bacteriostatic water and processing equipment used to prepare the compounded product.
- Check if you have semaglutide syringes from Carolina Infusion with lot 08262026@6
- Do not use the product if you have this lot
- Contact your healthcare provider or pharmacy for guidance on next steps
- Return the product to the pharmacy or place of purchase
The agency's original wording
Hazard
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
8 x 0.1 ml syringes
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0018-2027More Carolina Infusion recalls
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion Sermorelin Acetate injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion tirzepatide injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion tirzepatide/cyanocobalamin injectable recalled for sterility concerns
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