Drug recall: Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton…

US Nationwide.

GenoGenix LLC, Boca Raton, FL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

Drug events that started in 2025

322

Share of these events in Class I

9%

Product records in this event

57

Events of the firm on the register

1

• FDA enforcement report D-0038-2026The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Where was the product distributed?

The FDA record gives this distribution: US Nationwide.

What quantity of product is in FDA event 97369?

The event has 57 product records. The first record gives this quantity: 17

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many drug recalls of 2025 have the same class?

9% of the 322 drug events that started in 2025 are in Class I.