The Recall Desk
HighFDA (Drugs)·D-0657-2025·Announced 2025-09-24

Entecavir 1 mg tablets recalled after failing impurity and degradation specifications

Zydus Entecavir Tablets, USP, 1 mg, lot E309377, are recalled nationwide after failing impurity and degradation specifications. 4,440 bottles are affected.

What this means for you

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, 1 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 68382-921-06, are being recalled. The affected product is lot E309377 with an expiry of 11/30/2025, and the recall covers 4,440 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

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 E309377
  • Exp 11/30/2025

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · ENTECAVIR

Same category