Hydrocortisone Recall: Zydus for Injection 100 mg/vial
Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, distributed nationwide in the United States by Zydus Pharmaceuticals (USA) Inc., is being recalled due to failed impurities/degradation specifications. A total of 70,776 vials are affected, identified as Lot LB00047A and LB00048A with an expiration date of 03/2028.
| Brand | Zydus Pharmaceuticals (USA) Inc |
|---|---|
| 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. |
| Reason | Failed Impurities/Degradation Specifications. |
| Severity | moderate |
| Units affected | 70776 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any vials from Lot LB00047A or LB00048A.
- Verify your packaging for the lot number and expiration date; contact Zydus Pharmaceuticals (USA) Inc. for instructions on return or disposal.
- If you have used this product, consult your healthcare provider and report adverse events to your clinician or appropriate medical authorities.
How to identify the recalled item
| Lot / date codes | Lot #: LB00047A, LB00048A, Exp. Date 03/2028 |
|---|---|
| Lot / date codes | Lot #: LB00047A, LB00048A, Exp. Date 03/2028 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Zydus Pharmaceuticals (USA) Inc recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.