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.
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 tablets are an antiviral used to treat hepatitis B. They are prescription-only and require medical supervision.
Impurity or degradation can affect drug purity and potency, potentially compromising treatment efficacy.
This recall is not part of a broader industry pattern at this time.
Consumers and healthcare providers should stop use and consult a clinician for alternatives; no injuries reported in the data.
NDC on bottle, packaging insert, and the FDA recall page linked in notices
Refunds/replacements typically processed within several weeks after confirmation
Keep bottle packaging, recall notice, and correspondence with supplier for records
Product: Entecavir Tablets, USP 1 mg, 30 Tablets. Manufacturer: Zydus Lifesciences Ltd., Ahmedabad, India. Distributor: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 68382-921-06. Lot: E309377. Expiration: 11/30/2025. Quantity: 4,440 bottles. Sold nationwide in the U.S.
No specific incidents or injuries are reported in the provided data.
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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.
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.