Home / Recalls / Zydus Pharmaceuticals (USA) Inc / D-0102-2025

D-0102-2025 Class III Ongoing

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

Recall Details

Product Type
Drugs
Report Date
December 11, 2024
Initiation Date
November 14, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4404 packs

Product Description

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets

Reason for Recall

Labeling: Not Elsewhere Classified - Wrong NDC number

Distribution Pattern

USA Nationwide.

Code Information

Lot#: M408002, Exp 05/31/2026

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  • 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-0001-2026 Class II — Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus (September 24, 2025)
  • D-0657-2025 Class II — Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesc (September 4, 2025)