Zydus Hydrocortisone Sodium Succinate for Injection
Hydrocortisone Sodium Succinate for Injection failed impurities and degradation specifications.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Zydus Pharmaceuticals (USA) Inc. recalled Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, manufactured by Zydus Lifesciences Ltd., Vadodara, because it failed impurities and degradation specifications. The recall began October 1, 2026, and was added to the FDA's Enforcement Report on October 13, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial
- NDC
- 70710-1907-1
- Lot
- LB00047A
- LB00048A
Details
- Company began the recall
- Event ID
- 100017
- Company
- Zydus Pharmaceuticals (USA) Inc
- Hazard
- Impurity or degradation
- Quantity recalled
- 70776 vials
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
