Benztropine recalls

The FDA has published 3 recalls involving Benztropine since 2013. The latest was reported on 2 Jun 2021. Most were for particulate matter. Cardinal Health 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 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 2 Jun 2021

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 benztropine is recalled

Particulate Matter267%
Manufacturing (CGMP) Deviations133%

Companies

By year

2021133%
2013267%

All benztropine recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
2 Jun 2021Drug	CLASS II	Benztropine Mesylate Tablets, USP in all pack sizes recalled	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
4 Sep 2013Drug	CLASS II	Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/ Single Dose Vial recalled	Nexus Pharmaceuticals	Particulate Matter	Nationwide
17 Jul 2013Drug	CLASS II	Benztropine Mesylate Injection, USP, 2 mg/ (1 mg/ Single Dose Vial recalledBenztropine Mesylate	Fresenius Kabi USA	Particulate Matter	Nationwide

Should you stop taking Benztropine?

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.