Baclofen recalls

The FDA has published 3 recalls involving Baclofen since 2016. The latest was reported on 24 Dec 2025. Freedom 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 2016

Last 12 months1reported

Class I00% of total

Ongoing1latest 24 Dec 2025

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 1 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 baclofen is recalled

Companies

By year

2025133%
2018133%
2016133%

Ongoing baclofen recalls

1 active

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Drug	CLASS II	Baclofen Tablets USP, 10 mg recalled by Golden State Medical SupplyBaclofen	Golden State Medical Supply	Other	Nationwide

All baclofen recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Drug	CLASS II	Baclofen Tablets USP, 10 mg recalled by Golden State Medical SupplyBaclofen	Golden State Medical Supply	Other	Nationwide
28 Feb 2018Drug	CLASS II	Baclofen USP (Micronized) for prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide
27 Jan 2016Drug	CLASS II	Baclofen USP powder recalled by Freedom Pharmaceuticals	Freedom Pharmaceuticals	Packaging Defects	Nationwide

Should you stop taking Baclofen?

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.