CLASS II ONGOING Drug recall · Reported 8 Oct 2025 · FDA Enforcement Report
Entecavir Tablets, USP, 0.5 mg recalled by Zydus Pharmaceuticals (USA)
Zydus Pharmaceuticals is recalling Entecavir Tablets, USP, 0.5 mg, distributed nationwide in the US. The recall was initiated on 24 Sep 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0001-2026
- FDA event ID
- 97684
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Brand
- Entecavir
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Sep 2025
- FDA classified
- 2 Oct 2025
- Reported
- 8 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 24 Sep 2025 | Recall initiated by company | |
| 2 Oct 2025 | Classified by FDA | +8 days |
| 8 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Which lots are affected?
Lot#: E409308, Exp 12/31/2026
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97684| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Entecavir Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals (USA)Entecavir | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
Other Entecavir recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Entecavir Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals (USA)Entecavir | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Entecavir Tablets, USP, 0.5 mg recalled by Zydus Pharmaceuticals (USA)Entecavir | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Entecavir Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals (USA)Entecavir | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Entecavir Tablets 0.5 mg per container recalled by Hetero USAEntecavir | Hetero USA | Potency & Assay | NJ |
| Drug | CLASS II | Entecavir, Tablet, 0.5 mg recalled by Aidapak Services | Aidapak Services | Packaging Defects | 4 states |