Agency classClass IIOur severity:High FDA (Drugs)·D-0656-2025·Announced 2025-09-24

Entecavir tablets recalled after failing impurity and degradation specifications

Zydus Entecavir Tablets, USP, 0.5 mg, lot E309376, are recalled nationwide after failing impurity and degradation specifications. 4,344 bottles are affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a prescription medicine outside its impurity specification is a potential harm and no injuries are reported.

Plain-English summary

Entecavir Tablets, USP, 0.5 mg, in 30-tablet bottles and available on prescription only, manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India and distributed by Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey, NDC 68382-920-06, are being recalled. The affected product is lot E309376 with an expiry of 11/30/2025, and the recall covers 4,344 bottles distributed nationwide.

The recall was issued because the product failed impurity and degradation specifications. The FDA classified the action as Class II.

Patients should check the lot number on their bottle against the recall and should not stop taking a prescribed medicine without speaking to their pharmacist or prescriber about a replacement supply.

The recalled product

Product: ENTECAVIR (ENTECAVIR)
Brand: ENTECAVIR
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Category: Drug — Antiviral
Hazard: failed-specification
degradation-impurity
prescription-drug
class-ii
Affected units: 4,344

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot E309376
Exp 11/30/2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · ENTECAVIR

Moderate
Entecavir 1 mg tablets recalled for out of specification organic impurity
FDA (Drugs) · 2025-10-08
Moderate
Entecavir 0.5 mg tablets recalled for out of specification organic impurity
FDA (Drugs) · 2025-10-08
High
Entecavir 1 mg tablets recalled after failing impurity and degradation specifications
FDA (Drugs) · 2025-09-24
Moderate
Hetero USA Recalls Entecavir Tablets Due to Impurity Specification Failure
FDA (Drugs) · 2017-08-23

Same manufacturer · Zydus Pharmaceuticals (USA) Inc

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Severe
Erythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
Severe
Erythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
High
Icosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18

Same hazard · failed specification