FDA Issues Class II Recall for Aequita Compounded Semaglutide Products

Aequita Pharmacy LLC, based in Kirkland, Washington, has initiated a voluntary recall of multiple formulations of its compounded semaglutide + cyanocobalamin injection solutions. The recalled products include varying concentrations of semaglutide, from 0.22 mg to 2.67 mg per 0.5 mL, all combined with 0.25 mg cyanocobalamin. These sterile, subcutaneous, multidose vial injections were distributed in Massachusetts and stored under refrigeration. The total quantity affected spans over 1000 vials across 5 formulations. All recalled lots are still within their expiration dates.

The recall, classified as Class II by the US Food and Drug Administration (FDA) as of August 1, 2025, stems from a lack of processing controls—a serious compounding oversight that may impact product sterility, dosage accuracy, or stability. While no adverse events have been publicly reported and no formal press release has been issued, the issue could pose health risks if left unaddressed. The firm first alerted consignees via email on July 18, 2025. This action remains ongoing and was initiated independently by Aequita Pharmacy as a precautionary measure.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist primarily prescribed for the management of type 2 diabetes and increasingly used off-label for weight loss. The addition of cyanocobalamin (vitamin B12) is often intended to support energy metabolism and nerve function, although its combination in this context is not FDA-approved. Pharmacists should ensure these recalled products are immediately quarantined and returned per Aequita’s instructions to protect patient safety.