CLASS II Drug recall · Reported 23 Aug 2017 · FDA Enforcement Report
Entecavir Tablets 0.5 mg per container recalled by Hetero USA
Hetero USA is recalling Entecavir Tablets 0.5 mg per container, distributed in New Jersey. The recall was initiated on 20 Jul 2017 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-1095-2017
- FDA event ID
- 77846
- Recalling firm
- Hetero USA, Piscataway, NJ
- Brand
- Entecavir
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2017
- FDA classified
- 16 Aug 2017
- Reported
- 23 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 20 Jul 2017 | Recall initiated by company | |
| 16 Aug 2017 | Classified by FDA | +27 days |
| 23 Aug 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
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 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30
Where it was distributed
NJ
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Which lots are affected?
Lot # ENT17008, Exp 01/2019
Where was it sold?
NJ
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.
More recalls from Hetero USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium | Hetero USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Acyclovir Tablets, USP, 800 mg recalled by Hetero USAAcyclovir | Hetero USA | Other | Nationwide |
| Drug | CLASS III | Montelukast sodium tablets, 10 mg recalled by Hetero USAMontelukast Sodium | Hetero USA | Packaging Defects | 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, 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, Tablet, 0.5 mg recalled by Aidapak Services | Aidapak Services | Packaging Defects | 4 states |