Valproic acid recalls

The FDA has published 3 recalls involving Valproic acid since 2021. The latest was reported on 7 Jun 2023. Most were for manufacturing (cgmp) deviations. Morton Grove Pharmaceuticals 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 recalls3since 2021

Last 12 months0reported

Class I00% of total

Ongoing1latest 7 Jun 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why valproic acid is recalled

Manufacturing (CGMP) Deviations267%
Potency & Assay133%

Companies

By year

2023133%
2021267%

Ongoing valproic acid recalls

1 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Valproic Acid Oral Solution, USP, 250mg recalled by Akorn	Akorn	Potency & Assay	Nationwide

All valproic acid recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Valproic Acid Oral Solution, USP, 250mg recalled by Akorn	Akorn	Potency & Assay	Nationwide
6 Oct 2021Drug	CLASS II	Valproic Acid Oral Solution, USP, 500 mg/, 100 unit dose cups recalled	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021Drug	CLASS II	Valproic Acid Oral Solution USP, (250 mg/, 1 Pint recalled	Morton Grove Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Valproic 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.