Zydus Pharmaceuticals (USA) Inc 2025-10-08 Health serious FDA
Health · FDA · Recall #FDA-D-0002-2026
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus… Recall
Issued October 8, 2025 · Zydus Pharmaceuticals (USA) Inc
In October 2025, Zydus Pharmaceuticals (USA) Inc recalled the Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
What you should do
- 1 Stop using Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Zydus Pharmaceuticals (USA) Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Zydus Pharmaceuticals (USA) Inc
- Category
- Health
- Recall date
- October 8, 2025
- Units affected
- Not reported
- Sold at
- Distributed Nationwide in the USA
- Recall number
- FDA-D-0002-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Zydus Pharmaceuticals (USA) Inc has 31 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.