Entecavir 0.5 mg tablets recalled for out of specification organic impurity
Zydus is recalling 912 bottles of Entecavir Tablets USP 0.5 mg from one lot after an individual organic impurity returned an out-of-specification result.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a specification failure: the record identifies an out-of-specification impurity result without naming the impurity, describing a health consequence, or reporting any injury.
Plain-English summary
Entecavir Tablets, USP, 0.5 mg, in 30-count bottles, manufactured by Zydus Lifesciences Ltd. of Ahmedabad, India and distributed by Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey, are being recalled for failed impurity and degradation specifications, specifically an out-of-specification result for an individual organic impurity.
The recall covers 912 bottles from lot E409308 with an expiration date of 31 December 2026, carrying NDC 68382-920-06. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record does not name the impurity or state a health consequence, and reports no injuries. Entecavir is a prescription antiviral, so patients holding the affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- ENTECAVIR (ENTECAVIR)
- Brand
- ENTECAVIR
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Antiviral
- Hazard
- impurity
- out-of-specification
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: E409308
- Exp 12/31/2026
Distribution
Distributed nationwide across the United States.
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