UnratedDrug recall · FDA · Published September 24, 2025
Zydus Entecavir Tablets Recall: Impurity Risk in 0.5mg Dose
Zydus Pharmaceuticals recalls 0.5mg Entecavir tablets due to failed impurity tests. This medication is prescription-only and may contain unsafe levels of organic impurities.
“Zydus Entecavir Tablets Recall: Impurity Risk in 0.5mg Dose.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31770-zydus-entecavir-tablets-recall-impurity-risk-in-0-5mg-dose. Based on FDA recall #D-0001-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0001-2026%22&limit=1).
The FDA announced on September 24, 2025, that Zydus Pharmaceuticals (USA) Inc is recalling Entecavir Tablets, USP, 0.5 mg due to failed impurity specifications. The recall affects 912 bottles distributed nationwide.
The recall is due to an out-of-specification result for an individual organic impurity. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since March 14, 2012. Recent Zydus recalls include Mirabegron tablets on August 5, 2026, and Erythromycin tablets on April 29, 2026, both involving N-Nitroso impurity risks. Other recent recalls of similar products include JB Chemicals Enalapril tablets (April 23, 2026), Alembic Fesoterodine Tablets (December 16, 2025), and Unichem Bisoprolol/Hydrochlorothiazide Tablets (January 21, 2026).
How to tell if you have this one
Check for the 0.5 mg dose, 30-count bottle, and prescription label. The product was manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India and distributed by Zydus Pharmaceuticals (USA) Inc.
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-0001-2026 (September 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0001-2026 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.