Entecavir Tablets recall
FDA recall D-0002-2026 · initiated Sep 24, 2025
Zydus Pharmaceuticals (USA) Inc recalled Entecavir Tablets in Sep 2025 — an FDA Class II recall (D-0002-2026) because Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
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: 600 30-count bottles
Details
- Product
- Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Sep 24, 2025
- FDA report date
- Oct 8, 2025
Frequently asked
- Was Entecavir Tablets recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Entecavir Tablets in Sep 2025 — an FDA Class II recall (D-0002-2026) because Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity. 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-0002-2026 was: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
- 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: Distributed Nationwide in the USA. The recall covers these lots — Lot#: E409309, Exp 12/31/2026. 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-0002-2026.