Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, Ge...

FDA Recall #D-0076-2026 — Class II — July 30, 2025

Recall #D-0076-2026 Date: July 30, 2025 Classification: Class II Status: Ongoing

Product Description

Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIA Health.

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

All lots within expiry.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated