Entecavir Tablets recall
FDA recall D-0656-2025 · initiated Sep 4, 2025
Zydus Pharmaceuticals (USA) Inc recalled Entecavir Tablets in Sep 2025 — an FDA Class II recall (D-0656-2025) because Failed Impurity/Degradation Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurity/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4344 bottles
Details
- Product
- Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Sep 4, 2025
- FDA report date
- Sep 24, 2025
Frequently asked
- Was Entecavir Tablets recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Entecavir Tablets in Sep 2025 — an FDA Class II recall (D-0656-2025) because Failed Impurity/Degradation Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Entecavir Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0656-2025 was: Failed Impurity/Degradation Specifications
- Is a recalled Entecavir Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Entecavir Tablets are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot E309376; Exp 11/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0656-2025.