Entecavir Tablets 0 — Class II drug recall D-1095-2017
Terminated recall by Hetero USA Inc, reported 2017-08-23, distributed in NJ. Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the thr
| Recall number | D-1095-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hetero USA Inc, Piscataway, NJ, United States |
| Recall initiated | 2017-07-20 |
| Classified | 2017-08-16 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2019-02-27 |
| Distributed | NJ |
| Quantity | 5,664 bottles |
| Reason classes | specification failure |
| NDC | 31722-0833, 31722-0833-30, 31722-0833-31, 31722-0833-32, 31722-0833-90, 31722-0834, 31722-0834-30, 31722-0834-31, 31722-0834-32, 31722-0834-90 |
| Lot numbers | ENT17008 |
| Expiration dates | 2019-01 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1095-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.