Home / Recalls / Zydus Pharmaceuticals (USA) Inc / D-0001-2026

D-0001-2026 Class II Ongoing

Recalled by Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

Recall Details

Product Type
Drugs
Report Date
October 8, 2025
Initiation Date
September 24, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
912 30-count bottles

Product Description

Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.

Reason for Recall

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

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot#: E409308, Exp 12/31/2026

Other recalls by Zydus Pharmaceuticals (USA) Inc

  • D-0400-2026 Class II — Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured (March 9, 2026)
  • D-0295-2026 Class II — Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: S (December 30, 2025)
  • D-0247-2026 Class III — traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufacture (December 19, 2025)
  • D-0159-2026 Class II — Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Man (October 23, 2025)
  • D-0153-2026 Class II — clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottle (October 22, 2025)
  • D-0152-2026 Class II — clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottle (October 22, 2025)
  • D-0154-2026 Class II — clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottle (October 22, 2025)
  • D-0002-2026 Class II — Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus L (September 24, 2025)
  • D-0656-2025 Class II — Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Life (September 4, 2025)
  • D-0657-2025 Class II — Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesc (September 4, 2025)