CLASS II ONGOING Drug recall · Reported 14 Oct 2026 · FDA Enforcement Report
Tirzepatide/cyanocobalamin 26/2 MG/ML Injectable recalled
Carolina Infusion is recalling Tirzepatide/cyanocobalamin 26/2 MG/ML Injectable, distributed nationwide in the US. The recall was initiated on 10 Sep 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0027-2027
- FDA event ID
- 99867
- Recalling firm
- Carolina Infusion, Ridgeland, SC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Sep 2026
- FDA classified
- 8 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Diabetes Medication
Timeline
| 10 Sep 2026 | Recall initiated by company | |
| 8 Oct 2026 | Classified by FDA | +28 days |
| 14 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the U.S
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Which lots are affected?
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;
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 99867This product is part of a recall event; the main page for the event is Quad-mix( Papav/phento/alpros/trop) Injectable recalled.
More recalls from Carolina Infusion
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sermorelin Acetate 1 MG/ML Injectable recalled by Carolina Infusion | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Semaglutide 3 MG/ML Injectable, . syringes recalled by Carolina Infusion | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Semaglutide/cyanocobalamin 3/2 MG/ML Injectable recalled | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Semaglutide/cyanocobalamin 9/2 MG/ML Injectable recalled | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide 26 MG/ML Injectable recalled by Carolina Infusion | Carolina Infusion | Sterility | Nationwide |
Other Tirzepatide recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tirzepatide 26 MG/ML Injectable recalled by Carolina Infusion | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/cyanocobalamin 76/2 MG/ML Injectable recalled | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/cyanocobalamin 64/2 MG/ML Injectable recalled | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/cyanocobalamin 85/2 MG/ML Injectable recalled | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide Injection, 18mg/mL Sterile Multi-Dose Vial recalled | Apothecary Pharma | Sterility | Nationwide |