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.

FDA recall notice · announced October 21, 2026 · Zydus Pharmaceuticals (usa)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: LB00047A, LB00048A, Exp. Date 03/2028
Quantity: 70776 vials
Status: Ongoing
Products in this recall event:
- 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., Pe (D-0039-2027)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.