Ethambutol recalls

The FDA has published 2 recalls involving Ethambutol since 2013. The latest was reported on 18 Dec 2013. Most were for potency & assay. Lupin 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 recalls2since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 18 Dec 2013

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 1 50%Class III 1 50%

Why ethambutol is recalled

Potency & Assay2100%

Companies

Lupin Pharmaceuticals150%
West-ward Pharmaceutical150%

By year

20132100%

All ethambutol recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
18 Dec 2013Drug	CLASS III	Ethambutol Hydrochloride Tablets USP, 400 mg recalledEthambutol Hydrochloride	Lupin Pharmaceuticals	Potency & Assay	Nationwide
10 Apr 2013Drug	CLASS II	Ethambutol Hydrochloride Tablets recalled by West-ward Pharmaceutical	West-ward Pharmaceutical	Potency & Assay	Nationwide

Should you stop taking Ethambutol?

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.