Glatiramer recalls

The FDA has published 4 recalls involving Glatiramer since 2012. The latest was reported on 16 May 2018. Teva Pharmaceuticals USA 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 recalls4since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 16 May 2018

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why glatiramer is recalled

Companies

Teva Pharmaceuticals USA375%
Kroger Specialty Pharmacy125%

By year

2018125%
2013250%
2012125%

All glatiramer recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
16 May 2018Drug	CLASS II	Glatiramer Acetate 40 mg/mL recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
27 Nov 2013Drug	CLASS II	Copaxone (glatiramer acetate injection), 20 mg/ pre-filled syringe recalledCopaxone	Teva Pharmaceuticals USA	Particulate Matter	Nationwide
24 Apr 2013Drug	CLASS II	Copaxone (glatiramer acetate injection), 20 mg recalledCopaxone	Teva Pharmaceuticals USA	Packaging Defects	Nationwide
15 Aug 2012Drug	CLASS II	Copaxone (glatiramer acetate injection), 20mg/mL recalledCopaxone	Teva Pharmaceuticals USA	Other	Nationwide

Should you stop taking Glatiramer?

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.