Entecavir recalls

Entecavir products have been recalled 5 times, most recently on 8 Oct 2025. The recalling company is usually Zydus Pharmaceuticals (USA). The most common reason is potency & assay.

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

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.