Hetero USA Entecavir Tablets 0.5mg Recall: Impurity Risk in Drug
Hetero USA recalls Entecav: 0.5mg tablets with impurity levels exceeding safety limits. This drug may have unsafe chemical levels that could affect health. Consumers should contact the manufacturer for details.
Recall notice
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Contact the company
What happened, in plain English
Hetero USA has recalled Entecavir 0.5mg tablets due to a chemical impurity exceeding safety limits. This could pose a health risk to patients taking the medication. The recall affects prescription-only tablets sold with specific lot numbers. Read more at govinfonow.com/recall/41433-hetero-usa-entecavir-tablets-0-5mg-recall-impurity-risk-in.
Source Summary by GovInfoNow · govinfonow.com/recall/41433-hetero-usa-entecavir-tablets-0-5mg-recall-impurity-risk-in · Updated October 7, 2026 · FDA enforcement record: FDA #D-1095-2017
Cite this page
“Hetero USA Entecavir Tablets 0.5mg Recall: Impurity Risk in Drug.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41433-hetero-usa-entecavir-tablets-0-5mg-recall-impurity-risk-in. Based on FDA recall #D-1095-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1095-2017%22&limit=1).
Why it’s dangerous
The tablets contain an impurity level (0.33%) that exceeds the safety limit (0.20%). This impurity could potentially affect the drug's safety and effectiveness. The issue was detected at the three-month stability test.
Who’s affected
Prescription patients using Entecavir 0.5mg tablets with lot number ENT17008. Those with the specific NDC code 31722-833-30 are most at risk.
How to tell if you have this one
Check for the lot number ENT17008 on the packaging. The product has NDC code 31722-833-30 and was manufactured for Camber Pharmaceuticals, Inc. in Piscataway, NJ.
- Brand
Hetero USA- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number ENT17008 and NDC code 31722-833-30 on the packaging.
Where it went and when
Where it was distributed
Distributed in New Jersey.
FDA distribution: “NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1095-2017 (July 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1095-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.