FDA-Drug2026-10-21Class IICHEMICAL
Zydus Hydrocortisone Sodium Succinate for Injection recalled for failed impurities specifications
What this means
Zydus Pharmaceuticals is recalling specific lots of Hydrocortisone Sodium Succinate for Injection because the drug failed quality testing for impurities and degradation. The affected lots (LB00047A and LB00048A, expiring 03/2028) were distributed nationwide. No injuries have been reported.
- If you use this medication, contact your pharmacy or healthcare provider immediately with the lot number and vial information
- Do not use vials from lots LB00047A or LB00048A
- Return affected vials to the pharmacy where they were dispensed
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
70776 vials
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0039-2027More Zydus recalls
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