Carolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling specific lots of Tirzepatide/Cyanocobalamin 64/2 mg/mL injectable because the product may lack assurance of sterility.
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 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 specific lots of Tirzepatide/Cyanocobalamin 64/2 mg/mL injectable. The product is packaged in single-use dosage syringes and was distributed nationwide within the U.S. The recall is due to a lack of assurance of sterility related to the formulation using bacteriostatic water and the processing equipment used in the compounded product.
The affected lots are 07252026@3, 08112026@5, 08212026@21, and 08282026@3. The source does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- 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
- 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 (8)
- 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.
Distribution
Distributed nationwide across the United States.
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