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Class II · ModerateActive recall

Entecavir

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: E409309, Exp 12/31/2026
Where it was soldDistributed Nationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byZydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer
Brand nameENTECAVIR
Generic nameENTECAVIR
Active ingredient(s)ENTECAVIR
Distributed by / forZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
NDC68382-921-06
Show the full FDA record
Full product labelEntecavir 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.
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionDistributed Nationwide in the USA
Quantity600 30-count bottles
Recall initiated2025-09-24
Report date2025-10-08
Recall completed—
Recall numberD-0002-2026
ClassificationClass II
FDA statusOngoing
Origin on filePennington NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.