# FDA recall D-0076-2026

> **GenoGenix  LLC** · Class II · drug recall initiated 2025-07-30.

## 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

- **Recall number:** D-0076-2026
- **Recalling firm:** GenoGenix  LLC
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0076-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0076-2026. Source: US FDA. Licensed CC0.

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