Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Entecavir Tablets 0.5 mg Recalled by Hetero USA Inc Due to Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33%...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hetero USA Inc directly.
Affected Products
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
Quantity: 5664 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Where Was This Sold?
This product was distributed to 1 state: NJ
About Hetero USA Inc
Hetero USA Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report