Zydus Lifesciences and Zydus Pharmaceuticals USA recall 600 bottles of Entacavir 1 mg tablets distributed nationwide in the United States. An out-of-specification organic impurity triggered the recall. Stop use immediately and contact a healthcare provider or Zydus for guidance.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter
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Entacavir is an antiviral used to treat hepatitis B infection. It is prescribed by physicians and distributed to patients nationwide.
The product failed impurity/degradation specifications, indicating an organic impurity beyond acceptable limits, which could pose safety risks if consumed.
This recall is not indicated as part of a broader industry pattern in the provided data.
No incidents reported in the notice, but patients must stop use and consult their clinician to determine next steps.
Label shows lot number, expiration date, NDC code, and manufacturer information
Refunds or replacements processed per company policy after notification; no firm timeline provided
Keep recall notice, packaging, receipts, and communication logs with manufacturer for records
Model numbers: Lot# E409309. Expiration: 12/31/2026. Quantity: 600 bottles. Sold nationwide in the USA. Manufactured by Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC 68382-921-06.
No consumer injury or adverse event data provided in the recall notice.
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Zydus Pharmaceuticals USA Inc. recalls Entecavir tablets after FDA enforcement reports impurity/degradation failures. The recall affects 4,440 bottles distributed nationwide. Providers and patients should stop use and seek guidance from a healthcare professional.
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.
Zydus Lifesciences recall remains active for 270,125 vials distributed across MS, OH, LA and Puerto Rico. The FDA notice cites failed impurities and degradation specifications as the reason. Immediate discontinuation is advised for healthcare providers and patients with ongoing prescriptions. Contact Zydus Pharmaceuticals USA Inc for guidance.