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;
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
| Recalling firm | Carolina Infusion, LLC |
|---|---|
| Reason | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Sep 10, 2026 |
| Region | SC, United States |
| Distribution | Nationwide within the U.S |
| Quantity | 5.6 mLs - in patient specific syringe doses |
| Code/Lot | 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. |
| Type | Voluntary: Firm initiated |
| Recall number | D-0017-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: D-0017-2027)
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