Entecavir Tablet, Film Coated
FDA Recall NDC 68382-921
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Entecavir (NDC 68382-921). A significant event, classified as Class II, was initiated on Sep 24, 2025 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
September 2025 Class II Recall: Failed impurity/degradation specifications
Recall Number
Class II Ongoing
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Sep 24, 2025
Oct 08, 2025
912 30-count bottles
Recall Profile & Regulatory Data
Event ID
97684
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Batch or Lot Expiration Information
Lot# : E409308, Exp 12/31/2026
Affected Packages Involved in this Recall
68382-920-06Product
68382-920-16Product
68382-920-01Product
68382-920-30Product
68382-920-77Product
68382-921-06Product
68382-921-16Product
68382-921-01Product
68382-921-30Product
68382-921-77Product
September 2025 Class II Recall: Failed impurity/degradation specifications
Recall Number
Class II Ongoing
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Sep 24, 2025
Oct 08, 2025
600 30-count bottles
Recall Profile & Regulatory Data
Event ID
97684
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# : E409309, Exp 12/31/2026
Affected Packages Involved in this Recall
68382-920-06Product
68382-920-16Product
68382-920-01Product
68382-920-30Product
68382-920-77Product
68382-921-06Product
68382-921-16Product
68382-921-01Product
68382-921-30Product
68382-921-77Product
September 2025 Class II Recall: Failed Impurity/Degradation Specifications
Recall Number
Class II Ongoing
Failed Impurity/Degradation Specifications
Sep 04, 2025
Sep 24, 2025
4344 bottles
Recall Profile & Regulatory Data
Event ID
97556
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Batch or Lot Expiration Information
Lot# Lot E309376; Exp 11/30/2025
Affected Packages Involved in this Recall
68382-920-06Product
68382-920-16Product
68382-920-01Product
68382-920-30Product
68382-920-77Product
68382-921-06Product
68382-921-16Product
68382-921-01Product
68382-921-30Product
68382-921-77Product
September 2025 Class II Recall: Failed Impurity/Degradation Specifications
Recall Number
Class II Ongoing
Failed Impurity/Degradation Specifications
Sep 04, 2025
Sep 24, 2025
4440 bottles
Recall Profile & Regulatory Data
Event ID
97556
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Batch or Lot Expiration Information
Lot# Lot E309377, Exp 11/30/2025
Affected Packages Involved in this Recall
68382-920-06Product
68382-920-16Product
68382-920-01Product
68382-920-30Product
68382-920-77Product
68382-921-06Product
68382-921-16Product
68382-921-01Product
68382-921-30Product
68382-921-77Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
