FDAFDA recall D-0039-2027 · Oct 21, 2026
Zydus Pharmaceuticals (USA) Inc: Hydrocortisone Sodium Succinate for Injection recall
Recall found
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 for recall
Failed Impurities/Degradation Specifications.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: LB00047A, LB00048A, Exp. Date 03/2028
- Quantity
- 70776 vials
- Distribution
- Nationwide within the United States
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-10-01
Source: openFDA enforcement record D-0039-2027 · search recall number D-0039-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.