Quick Facts at a Glance
- Recall Date
- September 24, 2025
- Hazard Level
- HIGH
- Brands
- ENTECAVIR, ZYDUS PHARMACEUTICALS USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ENTECAVIR, ZYDUS PHARMACEUTICALS USA
- Product type
- Entecavir 0.5 mg tablets
- Model numbers
- Lot#: E409308
- UPC codes
- 68382-920, 68382-921, 68382-920-06, 68382-920-16, 68382-920-01, 68382-920-30, 68382-920-77, 68382-921-06 +4 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 24, 2025
Reported by FDA DRUG
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter
About This Product
Entecavir is an antiviral used to treat chronic hepatitis B in adults and some pediatric patients. It lowers the amount of hepatitis B virus in the body and reduces liver damage.
Why This Is Dangerous
The product failed impurity/degradation specifications. An individual organic impurity detected in the product could pose a health risk if consumed.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
If contaminated, patients may experience adverse effects from impurity exposure. Consumers should stop use and consult a clinician. There could be disruption to treatment plans.
Practical Guidance
How to identify if yours is affected
- Locate the bottle and check the label for NDC 68382-920-06
- Look for Lot E409308 on the bottle
- Verify Expiration Date 12/31/2026
- If the bottle matches, stop using it immediately and contact the distributor
Where to find product info
Identifiers appear on the bottle and outer packaging. The NDC is 68382-920-06. The lot is E409308 and the exp date is 12/31/2026.
What timeline to expect
Refunds or replacements are typically processed within 4-6 weeks after eligibility is confirmed.
If the manufacturer is unresponsive
- Document all communications with the company
- Escalate to the appropriate consumer protection agency if the company is non-responsive
- Consult your healthcare provider for interim treatment guidance
How to prevent similar issues
- Always verify NDC, lot, and expiration before taking any prescription medication
- Keep medication packages until you are sure you no longer need them
- Ask a pharmacist about recall status when receiving new prescriptions
Documentation advice
Keep the recall notice, bottle labels, receipts, and any correspondence. Photograph the product and packaging for your records.
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Product Details
Product: Entecavir Tablets, USP, 0.5 mg, 30-count bottle. NDC: 68382-920-06. Manufacturer: Zydus Lifesciences Ltd., Ahmedabad, India. Distributor: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. Lot number: E409308. Expiration: 12/31/2026. Quantity: 912 bottles. Sold nationwide in the USA. Recall date: 2025-09-24.
Reported Incidents
No injuries or incidents have been reported.
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Safety Guide
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