Hydrocortisone Sodium Succinate for Injection recall (Zydus Pharmaceuticals (USA) Inc)
DrugClass IIOngoing
Summary: Zydus Pharmaceuticals (USA) Inc is recalling 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.
What is being recalled
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.
Why
Failed Impurities/Degradation Specifications.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lot #: LB00047A, LB00048A, Exp. Date 03/2028
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0039-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | October 1, 2026 |
| Reported | October 21, 2026 |
| Company | Zydus Pharmaceuticals (USA) Inc |
| Company location | Pennington, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 70776 vials |
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