HYDROCORTISONE SODIUM SUCCINATE
Recalling Firm / Manufacturer: Zydus Pharmaceuticals (USA) Inc
(Pennington, NJ, United States)
FDA Recall Number: D-0039-2027
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
HYDROCORTISONE SODIUM SUCCINATE
Generic Name
HYDROCORTISONE SODIUM SUCCINATE
Active Substance(s)
Hydrocortisone Sodium Succinate
Administration Route
Intramuscular
National Drug Code (NDC)
70710-1907
Total Quantity Recalled
70776 vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Impurities/Degradation Specifications.
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
October 21, 2026
Firm Initiation Date
October 01, 2026
FDA Classification Date
Oct 13, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: LB00047A, LB00048A, Exp. Date 03/2028
Distribution Information
Geographic scope of affected shipments
Nationwide within the United States
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0039-2027
Questo Retrieval Date: October 27, 2026 00:00 1793059209UTCC