October 2026 FDA Recall Hydrocortisone Sodium Succinate by Zydus Pharmaceuticals (usa) Inc (D-0039-2027 - Failed Impurities/Degradation Specifications.)

This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on October 1, 2026 for the product Hydrocortisone Sodium Succinate. The FDA reported the reason for recall as failed impurities/degradation specifications.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0039-2027

Reason for Recall
Failed Impurities/Degradation Specifications.
Initiated
10-01-2026
Reported
10-21-2026
Quantity
70776 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
100017
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# : LB00047A, LB00048A, Exp. Date 03/2028

Affected Packages Involved in this Recall

70710-1907-1 Hydrocortisone Sodium Succinate