Quick Facts at a Glance
- Recall Date
- September 4, 2025
- Hazard Level
- HIGH
- Brands
- Zydus Pharmaceuticals USA Inc., Entecavir, Zydus Lifesciences Ltd.
- 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
- Zydus Pharmaceuticals USA Inc., Entecavir, Zydus Lifesciences Ltd.
- Product type
- Entecavir Tablets
- Model numbers
- Lot E309377, 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
- Sizes
- 30 Tablets
- 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 tablets are an antiviral used to treat hepatitis B. They are prescription-only and require medical supervision.
Why This Is Dangerous
Impurity or degradation can affect drug purity and potency, potentially compromising treatment efficacy.
Industry Context
This recall is not part of a broader industry pattern at this time.
Real-World Impact
Consumers and healthcare providers should stop use and consult a clinician for alternatives; no injuries reported in the data.
Practical Guidance
How to identify if yours is affected
- Locate bottle with NDC 68382-921-06
- Check Lot E309377 and Exp 11/30/2025
- Verify 30-tablet packaging and Rx Only designation
Where to find product info
NDC on bottle, packaging insert, and the FDA recall page linked in notices
What timeline to expect
Refunds/replacements typically processed within several weeks after confirmation
If the manufacturer is unresponsive
- Document all communications
- Escalate to FDA consumer complaint if necessary
- Consult healthcare provider for interim treatment options
How to prevent similar issues
- Verify NDC before dispensing medications
- Maintain inventory controls to isolate recalled lots
- Monitor FDA recall updates for new information
Documentation advice
Keep bottle packaging, recall notice, and correspondence with supplier for records
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Product Details
Product: Entecavir Tablets, USP 1 mg, 30 Tablets. Manufacturer: Zydus Lifesciences Ltd., Ahmedabad, India. Distributor: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 68382-921-06. Lot: E309377. Expiration: 11/30/2025. Quantity: 4,440 bottles. Sold nationwide in the U.S.
Reported Incidents
No specific incidents or injuries are reported in the provided data.
Key Facts
- Distributed nationwide in the U.S.
- High hazard level
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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