FDA Drug recall D-0028-2027
TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
- FDA Drug
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p… by Carolina Infusion, citing lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0028-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-10 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Carolina Infusion |
| Distribution | US |
Product
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
Reason
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Carolina Infusion
- SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
FDA Drug · Class II · 2026-10-14 · Carolina Infusion - Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
FDA Drug · Class II · 2026-10-14 · Carolina Infusion - SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient pres…
FDA Drug · Class II · 2026-10-14 · Carolina Infusion - SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific pa…
FDA Drug · Class II · 2026-10-14 · Carolina Infusion - TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
FDA Drug · Class II · 2026-10-14 · Carolina Infusion
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0028-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.