entecavirdrugHigh PriorityActive

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

entecavir Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. recalled by FDA. Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

By RecallRadar Editorial Team

Sourced from FDA. Last reviewed March 4, 2026.

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: September 24, 2025
Last reviewed by RecallRadar: March 4, 2026

What You Should Do

1## Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-
2Agency: FDA | Category: drug Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity What to do:
3Stop using the product if your lot/model matches.
4Check the FDA notice for specifics.

Open Official Recall Notice Get Alerts for entecavir Devices

What's Being Recalled

Quoted source excerpt from the official notice.

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot#: E409309, Exp 12/31/2026

#	Model
1	Lot#: E409309, Exp 12/31/2026

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

Frequently Asked Questions

Is my entecavir device affected?

Check the affected models section on this page. The official notice currently lists Lot#: E409309, Exp 12/31/2026.

What is the remedy for this recall?

## Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. Agency: FDA | Category: drug Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: entecavir recall hub and Food & Drug recall hub.