FDA Issues Class II Recall for Compounded Semaglutide/Cyanocobalamin Injectable Due to Lack of Sterility Assurance

What this means for your practice

This recall serves as a critical reminder for all healthcare businesses, including telehealth brands, medspas, and general practices, that prescribe or administer compounded medications, especially injectables. The primary concerns, lack of sterility assurance due to formulation practices (bacteriostatic water) and processing equipment, highlight inherent risks associated with non-FDA-approved compounded products. Practices must ensure that any compounded medications sourced are from reputable compounding pharmacies with robust quality control processes that meet current Good Manufacturing Practices (cGMP) standards, even if they are not explicitly FDA-approved. This event underscores the importance of stringent vendor vetting, clear communication with patients regarding the status of their medications, and a thorough understanding of compounding pharmacy regulations. Providers should review their policies for prescribing and procuring compounded injectables to mitigate patient safety risks and regulatory exposure.

The U.S. Food and Drug Administration (FDA) has announced a Class II recall for a compounded injectable medication, Semaglutide/Cyanocobalamin 9/2 mg/mL, distributed by Carolina Infusion LLC. The recall, identified as D-0026-2027, was initiated on September 10, 2026, and reported on October 14, 2026. This action impacts product packaged in single-use dosage syringes, with total milliliters dispensed varying based on individual patient prescriptions.

Reason for the Recall

The primary reason for this recall is a critical "Lack of Assurance of Sterility." This sterility concern is specifically attributed to two factors:

1. Formulation using bacteriostatic water: The use of bacteriostatic water in the formulation process has been identified as a contributing factor to the lack of sterility assurance. While bacteriostatic water contains antimicrobial agents, its use in certain formulations or processing environments may not guarantee the necessary level of sterility for injectable products.
2. Processing equipment used in compounded product: Issues related to the processing equipment utilized by Carolina Infusion LLC in the compounding of this product also contributed to the sterility concerns. Proper sterilization and maintenance of equipment are paramount in producing safe injectable medications.

Affected Product and Distribution

The recalled product is SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE. It is supplied in single-use dosage syringes, with the dispensed volume tailored to specific patient prescriptions. The compounding firm, Carolina Infusion LLC, is located at 95 Bees Creek Road, Ridgeland, SC 29936.

The distribution of this recalled injectable medication was widespread, reaching patients and healthcare providers nationwide within the U.S.

Regulatory Context of Compounded Drugs and Sterility

Compounded drugs, while vital for meeting specific patient needs not addressed by commercially available products, are not FDA-approved. This means they do not undergo the same rigorous pre-market evaluation for safety, efficacy, and quality as manufactured drugs. However, compounding pharmacies are subject to federal and state regulations, particularly regarding good compounding practices and sterility for sterile preparations like injectables.

Sterility assurance is foundational for injectable medications, as non-sterile products can introduce dangerous microorganisms directly into a patient's bloodstream, leading to severe infections, sepsis, and even death. The FDA's classification of this as a Class II recall indicates that the 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 specific recall highlights the FDA's ongoing oversight of compounded medications, particularly when sterility is compromised. Compounding pharmacies are expected to adhere to standards such as those outlined in USP (United States Pharmacopeia) General Chapters, including USP <797> Pharmaceutical Compounding—Sterile Preparations, to ensure the quality and safety of their products. Failures in maintaining these standards, whether through improper formulation choices or deficiencies in equipment and processes, can lead to significant public health risks and regulatory actions.

Implications for Healthcare Providers

For healthcare providers who utilize compounded medications, this recall underscores several critical points:

• Vendor Due Diligence: It is imperative for all practices, including telehealth, medspas, dental offices, and chiropractic clinics, to exercise extreme due diligence when selecting and monitoring compounding pharmacies. Verify the pharmacy's accreditation, regulatory history, and adherence to sterile compounding standards.
• Patient Safety First: Immediately identify any patients who may have received the recalled product. Implement protocols for patient notification, assessment for adverse effects, and appropriate medical management.
• Documentation and Traceability: Maintain meticulous records of all compounded medications purchased, including lot numbers, expiration dates, and the specific compounding pharmacy. This enables rapid identification and response in the event of a recall.
• Understanding Compounding Risks: Be fully aware that compounded drugs, particularly injectables, carry inherent risks that differ from those associated with FDA-approved, mass-manufactured drugs. Educate patients on these differences when prescribing compounded options.
• Regulatory Compliance: Ensure that your practice's prescribing and dispensing protocols for compounded drugs align with both federal and state regulations. Some states have specific rules regarding the use of compounded medications in office-use settings or for specific specialties.

This ongoing recall serves as a significant regulatory intelligence update, reinforcing the need for continuous vigilance in ensuring the safety and quality of all medications administered to patients, especially those sourced from compounding pharmacies.

Key Facts

Frequently Asked Questions

What product is subject to this FDA recall?

The product subject to this recall is SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, packaged in single-use dosage syringes.

Who initiated this recall?

The recall was initiated by Carolina Infusion, LLC.

Why was this injectable product recalled?

The product was recalled 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.

Where was this recalled product distributed?

The recalled product was distributed nationwide within the U.S.

What is the status of this recall?

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

Source: FDA — FDA Recall D-0026-2027: SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage s · 2026-10-14