Drug FDA Class II Ongoing Failed specifications

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

Zydus Pharmaceuticals (USA) Inc Published Oct 8, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Zydus Pharmaceuticals (USA) Inc or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Hazards

Organic Impurity Out of Specification · primary

Affected products (1)

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

ENTECAVIR · 600 30-count bottles

NDC: 68382-920, 68382-921, 68382-920-06, 68382-920-16, 68382-920-01, 68382-920-30, 68382-920-77, 68382-921-06, 68382-921-16, 68382-921-01, 68382-921-30, 68382-921-77

Code info: Lot#: E409309, Exp 12/31/2026

Affected areas

Nationwide

Timeline

Initiated

Sep 24, 2025
Published

Oct 8, 2025

Recall number: D-0002-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.