Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW ...

FDA Recall #D-0091-2026 — Class II — July 30, 2025

Recall #D-0091-2026 Date: July 30, 2025 Classification: Class II Status: Ongoing

Product Description

Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

GenoGenix LLC — Boca Raton, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

US Nationwide.

Code Information

Lot#: GG021125-001, GG031125-017, within expiry.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated