D-0039-2027 Class II Ongoing
FDA drug recall D-0039-2027 was initiated by Zydus Pharmaceuticals (USA) Inc on Oct 1, 2026 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications. The recall status is ongoing. Affected quantity: 70776 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 21, 2026
- Initiation Date
- Oct 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70776 vials
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.
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: LB00047A, LB00048A, Exp. Date 03/2028
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0039-2027
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026