Alpha Lipoic Acid recalls

The FDA has published 5 recalls involving Alpha Lipoic Acid since 2013. The latest was reported on 15 Oct 2025. Most were for sterility. GenoGenix has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls5since 2013

Last 12 months0reported

Class I00% of total

Ongoing2latest 15 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 1 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why alpha lipoic acid is recalled

Sterility5100%

Companies

By year

2025120%
2022240%
2016120%
2013120%

Ongoing alpha lipoic acid recalls

2 active

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Alpha Lipoic Acid for Injection, all strengths recalled by GenoGenix	GenoGenix	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Alpha Lipoic Acid 25mg/mL-vial, Refrigerate, Tailor Made Compounding recalled	TMC Acquisition	Sterility	Nationwide

All alpha lipoic acid recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Alpha Lipoic Acid for Injection, all strengths recalled by GenoGenix	GenoGenix	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Alpha Lipoic Acid 25mg/mL-vial, Refrigerate, Tailor Made Compounding recalled	TMC Acquisition	Sterility	Nationwide
1 Jun 2022Drug	CLASS II	Alpha Lipoic Acid 25 mg/mL, Multi-Dose vial recalled	Olympia Compounding Pharmacy	Sterility	Nationwide
15 Jun 2016Drug	CLASS II	Alpha Lipoic Acid 25mg/ML recalled by Well Care Compounding Pharmacy	Well Care Compounding Pharmacy	Sterility	NV
22 May 2013Drug	CLASS II	Alpha Lipoic Acid Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide

Should you stop taking Alpha Lipoic Acid?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.