FDA Recall D-0027-2027: Compounded Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns

What this means for your practice

This recall underscores the critical importance of rigorous vendor due diligence and adherence to sterility protocols for all healthcare businesses, including telehealth brands, medspas, dental practices, and chiropractic offices, that prescribe or administer compounded injectable medications. Practices must confirm that their compounding pharmacy partners maintain the highest standards of quality control and sterile processing. The use of bacteriostatic water and issues with processing equipment highlight common areas where sterility can be compromised in compounding. Failure to ensure sterility not only poses significant patient safety risks but also exposes practices to substantial regulatory and legal liabilities. Providers should immediately review their inventory for the recalled product and assess their current sourcing practices for all compounded injectables to mitigate future risks.

Washington D.C. — The U.S. Food and Drug Administration (FDA) has announced a Class II recall (D-0027-2027) for a compounded injectable medication containing Tirzepatide and Cyanocobalamin. The product, identified as TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, was packaged in single-use dosage syringes and distributed nationwide within the United States.

Details of the Recall

The recall was initiated by Carolina Infusion LLC, located at 95 Bees Creek Road, Ridgeland, SC 29936. The primary reason for the recall is a "Lack of Assurance of Sterility." This sterility concern is specifically linked to two critical aspects of the compounding process: the formulation, which involved the use of bacteriostatic water, and issues related to the processing equipment utilized in the compounded product's manufacturing.

The recall officially commenced on September 10, 2026, and was reported by the FDA on October 14, 2026. As of the latest update, the recall is ongoing, indicating that efforts to retrieve the affected product from the market are still in progress. The nationwide distribution means that healthcare providers and patients across the country may have received this product.

Understanding Class II Recalls

An FDA Class II recall is issued when a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. In the case of injectables, a lack of sterility can lead to severe infections, sepsis, and other life-threatening conditions, making the classification of this recall as Class II a serious matter for patient safety.

Implications for Compounded Medications

This recall highlights ongoing regulatory scrutiny and inherent risks associated with compounded medications, particularly injectables. Compounded drugs are custom-prepared medications for individual patients based on a prescription from a licensed practitioner. While compounding plays a vital role in meeting specific patient needs—such as customizing dosages, removing allergens, or preparing medications not commercially available—it is subject to strict quality and sterility standards.

The concerns raised by this recall—the use of bacteriostatic water in formulation and issues with processing equipment—are critical. Bacteriostatic water is typically intended for multi-dose vials for certain specific uses, but its application in the formulation of a compounded product can introduce risks if not handled correctly and appropriately for the specific drug and route of administration, especially when sterility is paramount for injectables. Furthermore, problems with processing equipment can compromise the sterile environment necessary to prevent microbial contamination, leading to potential infections when administered to patients.

Due Diligence for Healthcare Providers

For telehealth brands, medspas, dental practices, chiropractic offices, and other healthcare operators that utilize compounded medications, especially injectables, this recall serves as a stark reminder of the importance of robust due diligence. Providers are ultimately responsible for the safety and efficacy of the medications they prescribe and administer. This includes ensuring that any compounding pharmacy they partner with adheres to the highest standards of quality assurance, good manufacturing practices (GMP), and sterile compounding regulations.

Practitioners should:

• Verify Sourcing: Confirm that all compounded medications, especially injectables, are sourced from reputable and appropriately licensed compounding pharmacies that adhere to federal and state guidelines, including USP <797> and <800> standards for sterile and hazardous compounding.
• Review Recall Notices: Stay informed about FDA recall notices and promptly check their inventory for any affected products.
• Assess Internal Protocols: Ensure that internal protocols for handling, storage, and administration of injectables maintain sterility and prevent contamination.
• Patient Communication: Be prepared to identify and contact patients who may have received the recalled product and provide appropriate guidance in consultation with prescribing physicians.

Conclusion

The nationwide recall of compounded Tirzepatide/Cyanocobalamin injectable by Carolina Infusion LLC due to sterility concerns is a critical regulatory development. It emphasizes the need for continuous vigilance and stringent quality controls within the compounding industry and among healthcare providers who rely on these specialized preparations. Prioritizing patient safety through rigorous adherence to regulatory standards and careful selection of compounding partners remains paramount.

Key Facts

Frequently Asked Questions

What specific product is being recalled?

The recalled product is TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, packaged in single-use dosage syringes, with the total mL dispensed based on specific patient prescriptions.

Why was this compounded injectable recalled?

The recall was initiated due to a lack of assurance of sterility, specifically related to the formulation using bacteriostatic water and issues with the processing equipment used in the compounded product.

Which firm initiated this recall?

The recall was initiated by Carolina Infusion, LLC, located in Ridgeland, SC.

Where was the recalled product distributed?

The product was distributed nationwide within the United States.

What is the current status of the recall?

The recall is ongoing, having been initiated on September 10, 2026, and reported on October 14, 2026.

Source: FDA — FDA Recall D-0027-2027: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage · 2026-10-14