Drug recall
Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca…
FDA recall event 97369 · Class I, Class II · GenoGenix LLC
Key facts
| Event ID | 97369 |
|---|---|
| Recall numbers | D-0038-2026, D-0039-2026, D-0040-2026, D-0041-2026, D-0042-2026, D-0043-2026, D-0044-2026, D-0045-2026, D-0046-2026, D-0047-2026, D-0048-2026, D-0049-2026 and 45 more |
| Recalling firm | GenoGenix LLC |
| Product type | Drugs |
| Products | Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692., Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692, Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692., Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692., B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. and 52 more |
| Classification | Class I, Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility, Microbial Contamination of Sterile Products: elevated endotoxin levels |
| Initiation date | Jul 30, 2025 |
| Report date | Oct 15, 2025 |
| City | Boca Raton |
| State | FL |
| Country | United States |
| FEI number | 3032144832 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: