Class IIDrugOngoing

Zydus Pharmaceuticals (USA) Inc

Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.

Reason for recall

Failed Impurities/Degradation Specifications.

Details

Recall number: D-0039-2027
Event ID: 100017
Recall initiated: Oct 1, 2026
Classified: Oct 13, 2026
Reported: Oct 21, 2026
Quantity: 70776 vials
Distribution: Nationwide within the United States
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Pennington, NJ, United States
Lot / code info: Lot #: LB00047A, LB00048A, Exp. Date 03/2028