Zydus Pharmaceuticals USA Inc. recalls 4,344 bottles of Entecavir tablets nationwide over impurity/degradation specification failures. The product, Entecavir Tablets, 0.5 mg, carries NDC 68382-920-06 and Lot E309376 with Exp 11/30/2025. The recall is active as of Sept. 24, 2025.
Failed Impurity/Degradation Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A
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Entecavir is an antiviral medication used to treat hepatitis B. The 0.5 mg tablet is intended for adult patients requiring chronic hepatitis B management.
The recall is due to impurities and potential degradation products that may affect safety and efficacy.
This recall is not part of a broader industry pattern
Immediate stop-use is advised. Patients should consult healthcare providers for guidance and potential switch to alternative therapies.
FDA recall page D-0656-2025; Zydus Pharmaceuticals USA Inc.
Refunds or replacements procedures are determined by the distributor and manufacturer; notice will be provided by official channels.
Keep bottle labels, recall notices, and all correspondence with the manufacturer for records.
Product: Entecavir Tablets, USP 0.5 mg, 30 tablets per bottle. Manufacturer: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 68382-920-06. Lot: E309376. Exp: 11/30/2025. Quantity: 4344 bottles. Distribution: Nationwide in the United States.
No injuries or incidents are documented in the recall notice.
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