Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd
Summary
The FDA issued a Class II for Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, by Zydus Pharmaceuticals (USA) Inc. Reason: Failed Impurities/Degradation Specifications..
Details
Source
Drug Recall
External ID
D-0039-2027
Action Date
2026-10-21
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot #: LB00047A, LB00048A, Exp. Date 03/2028
Quantity Affected: 70776 vials
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-10-01
Company
Pennington, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 62 drug-related FDA actions this month.
Zydus Pharmaceuticals (USA) Inc has 48 FDA actions in our database, including 48 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zydus Pharmaceuticals (USA) Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zydus Pharmaceuticals (USA) Inc have FDA actions?
Zydus Pharmaceuticals (USA) Inc has 48 FDA actions in our database, including 48 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0039-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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