Entecavir recalls

The FDA has published 5 recalls involving Entecavir since 2017. The latest was reported on 8 Oct 2025. Most were for potency & assay. Zydus 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 recalls5since 2017

Last 12 months4reported

Class I00% of total

Ongoing4latest 8 Oct 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 2 2Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why entecavir is recalled

Potency & Assay5100%

Companies

Zydus Pharmaceuticals (USA)480%
Hetero USA120%

By year

2025480%
2017120%

Ongoing entecavir recalls

4 active

Reported	Class	Recall	Company	Reason	Where
8 Oct 2025Drug	CLASS II	Entecavir Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
8 Oct 2025Drug	CLASS II	Entecavir Tablets, USP, 5 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
24 Sep 2025Drug	CLASS II	Entecavir Tablets, USP, 5 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
24 Sep 2025Drug	CLASS II	Entecavir Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide

All entecavir recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
8 Oct 2025Drug	CLASS II	Entecavir Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
8 Oct 2025Drug	CLASS II	Entecavir Tablets, USP, 5 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
24 Sep 2025Drug	CLASS II	Entecavir Tablets, USP, 5 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
24 Sep 2025Drug	CLASS II	Entecavir Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
23 Aug 2017Drug	CLASS II	Entecavir Tablets 5 mg per container recalled by Hetero USAEntecavir	Hetero USA	Potency & Assay	NJ

Should you stop taking Entecavir?

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.