Entecavir tablets recalled after failing impurity and degradation specifications
Zydus Entecavir Tablets, USP, 0.5 mg, lot E309376, are recalled nationwide after failing impurity and degradation specifications. 4,344 bottles are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a prescription medicine outside its impurity specification is a potential harm and no injuries are reported.
Plain-English summary
Entecavir Tablets, USP, 0.5 mg, in 30-tablet bottles and available on prescription only, manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India and distributed by Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey, NDC 68382-920-06, are being recalled. The affected product is lot E309376 with an expiry of 11/30/2025, and the recall covers 4,344 bottles distributed nationwide.
The recall was issued because the product failed impurity and degradation specifications. The FDA classified the action as Class II.
Patients should check the lot number on their bottle against the recall and should not stop taking a prescribed medicine without speaking to their pharmacist or prescriber about a replacement supply.
The recalled product
- Product
- ENTECAVIR (ENTECAVIR)
- Brand
- ENTECAVIR
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Antiviral
- Hazard
- failed-specification
- degradation-impurity
- prescription-drug
- class-ii
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 E309376
- Exp 11/30/2025
Distribution
Distributed nationwide across the United States.
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