FDA recall D-0076-2026

Product

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

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2025-07-30

Report date

2025-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0076-2026