Zydus Pharmaceuticals recalls 1 mg Entecavir tablets due to failed impurity specifications. Patients should contact their doctor for guidance on safe use.
“Zydus Entecavir Tablets Recall: Failed Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31803-zydus-entecavir-tablets-recall-failed-impurity-risk. Based on FDA recall #D-0657-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0657-2025%22&limit=1).
Zydus Pharmaceuticals (USA) Inc., distributed by Zydus Lifesciences Ltd., voluntarily recalled Entecavir Tablets, USP, 1 mg because they failed impurity and degradation specifications, the Food and Drug Administration said on Sept. 4, 2025.
How to tell if you have it
Brand: Zydus Pharmaceuticals
Product: Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only
Manufacturer: Zydus Lifesciences Ltd., Ahmedabad, India
The recalled Entecavir Tablets failed impurity and degradation specifications, according to the FDA recall record.
Context
GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since March 14, 2012. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (Aug. 5, 2026), Zydus Erythromycin Tablets Recall (April 29, 2026), and Zydus Recalls Icosapent Ethyl Capsules Due to Defects (March 9, 2026). Other recent recalls of similar products include Sagent Busulfan Injection Recall (May 4, 2026), Sun Pharmaceutical Fexofenadine 180mg Tablets Recall (June 1, 2026), and Alembic Fesoterodine Tablets Recall (Dec. 16, 2025).
How to tell if you have this one
Check for the product name 'Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only' with NDC 68382-921-06. The lot number E309377 was manufactured in India and expires November 30, 2025.
Brand
Zydus Pharmaceuticals
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
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-0657-2025 (September 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0657-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.