FDA Drugs recall ·
Proline for Injection, all strengths and presentations, GenoGenix, LLC… recall
- Recall number
- D-0079-2026
- Date
- (initiated July 30, 2025)
- Company / brand
- GenoGenix LLC
2840 Nw 2nd Ave Ste 204, Boca Raton, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots within expiry.
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0079-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.