Carolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 26/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II due to a lack of assurance of sterility in an injectable product. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 26/2 mg/mL injectable, packaged in single-use dosage syringes. The recall is due to a lack of assurance of sterility, which is related to the formulation using bacteriostatic water and the processing equipment used in the compounded product.
The affected product was distributed nationwide within the U.S. The source text does not specify the total number of units recalled or the specific patient populations affected beyond the general distribution pattern.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- 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
- Manufacturer
- Carolina Infusion, LLC
- Category
- Drug — Injectable
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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
Distribution
Distributed nationwide across the United States.
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