Quick Facts at a Glance
- Recall Date
- September 24, 2025
- Hazard Level
- HIGH
- Brands
- Entacavir, Zydus Pharmaceuticals USA Inc.
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Entacavir, Zydus Pharmaceuticals USA Inc.
- Product type
- Antiviral Tablet
- Model numbers
- LotE409309
- 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
- Unknown
- 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
Entacavir is an antiviral used to treat hepatitis B infection. It is prescribed by physicians and distributed to patients nationwide.
Why This Is Dangerous
The product failed impurity/degradation specifications, indicating an organic impurity beyond acceptable limits, which could pose safety risks if consumed.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
No incidents reported in the notice, but patients must stop use and consult their clinician to determine next steps.
Practical Guidance
How to identify if yours is affected
- Verify lot number E409309 on the bottle
- Check expiration date 12/31/2026
- Confirm NDC 68382-921-06 on packaging
Where to find product info
Label shows lot number, expiration date, NDC code, and manufacturer information
What timeline to expect
Refunds or replacements processed per company policy after notification; no firm timeline provided
If the manufacturer is unresponsive
- Escalate with FDA recall portal or consumer protection office
- Seek guidance from healthcare provider while pursuing replacement
How to prevent similar issues
- Always verify lot numbers and expiration dates before dispensing medications
- Report any adverse events to FDA MedWatch
- Review drug recall notices from FDA for antiviral medications
Documentation advice
Keep recall notice, packaging, receipts, and communication logs with manufacturer for records
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Product Details
Model numbers: Lot# E409309. Expiration: 12/31/2026. Quantity: 600 bottles. Sold nationwide in the USA. Manufactured by Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC 68382-921-06.
Reported Incidents
No consumer injury or adverse event data provided in the recall notice.
Key Facts
- Distributed nationwide in USA
- High hazard level
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Safety Guide
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