Quick Facts at a Glance
- Recall Date
- September 4, 2025
- Hazard Level
- HIGH
- Brands
- Zydus Lifesciences Ltd., Zydus Pharmaceuticals USA Inc., Entecavir
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- Zydus Lifesciences Ltd., Zydus Pharmaceuticals USA Inc., Entecavir
- Product type
- Prescription Drug Tablets
- Model numbers
- Lot E309376, Exp 11/30/2025
- 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 4, 2025
Reported by FDA DRUG
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurity/Degradation Specifications
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: N/A
About This Product
Entecavir is an antiviral medication used to treat hepatitis B. The 0.5 mg tablet is intended for adult patients requiring chronic hepatitis B management.
Why This Is Dangerous
The recall is due to impurities and potential degradation products that may affect safety and efficacy.
Industry Context
This recall is not part of a broader industry pattern
Real-World Impact
Immediate stop-use is advised. Patients should consult healthcare providers for guidance and potential switch to alternative therapies.
Practical Guidance
How to identify if yours is affected
- Verify NDC 68382-920-06 on the bottle label.
- Check Lot E309376 and Exp 11/30/2025.
- Confirm bottle count matches 30 tablets per bottle and total quantity 4,344 bottles.
Where to find product info
FDA recall page D-0656-2025; Zydus Pharmaceuticals USA Inc.
What timeline to expect
Refunds or replacements procedures are determined by the distributor and manufacturer; notice will be provided by official channels.
If the manufacturer is unresponsive
- Document all contacts, call the company again, and contact the FDA for escalation.
- File a consumer complaint with the FDA if needed.
How to prevent similar issues
- When buying prescription medications, verify the NDC and batch details.
- Avoid counterfeit sources; rely on licensed distributors.
- Consult healthcare providers before switching medications.
Documentation advice
Keep bottle labels, recall notices, and all correspondence with the manufacturer for records.
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Product Details
Product: Entecavir Tablets, USP 0.5 mg, 30 tablets per bottle. Manufacturer: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 68382-920-06. Lot: E309376. Exp: 11/30/2025. Quantity: 4344 bottles. Distribution: Nationwide in the United States.
Reported Incidents
No injuries or incidents are documented in the recall notice.
Key Facts
- Active recall as of 2025-09-04
- Nationwide distribution in the U.S.
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Safety Guide
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