Class II · Moderate risk
Entecavir Tablets
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Entecavir Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
68382-0921-06
Compare with the code on your package — it is the most precise check available.
Drug: Entecavir
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Entecavir NDC 68382-0921 |
1 mg/1 | Tablet, Film Coated Oral |
Zydus Pharmaceuticals USA Inc. | Rx |
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- NDC code
- 68382-921-06
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0002-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Entecavir recalls
See all
Class II · Moderate risk
Entecavir Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Entecavir Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Entecavir Tablets 0.5 mg
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Class II · Moderate risk
Entecavir
Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD30140_25, EXP: 5/7/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: W003686, EXP: 6/26/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD60272_49, EXP: 5/22/2014.
Other recalls by Zydus Pharmaceuticals (USA) Inc
All 2025 recalls
Class II · Moderate risk
Mirabegron Extended-Release Tablets
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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