Entecavir Tablets (Hetero USA) – Impurity Specification Failure (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Hetero USA Inc
Lot Codes / Batch Numbers
Lot # ENT17008, Exp 01/2019
Products Sold
Lot # ENT17008, Exp 01/2019
Hetero USA Inc is recalling Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceutical due to Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NJ
Page updated: Jan 7, 2026