Zydus Pharmaceuticals (USA) Inc. has voluntarily recalled 70,776 vials of Hydrocortisone Sodium Succinate for Injection, USP, 100 mg/vial, following quality testing that found the product did not meet specified impurity and degradation limits. The medicine was manufactured at Zydus Lifesciences’ facility in Vadodara, Gujarat, and distributed across the United States.
The recall was initiated on October 1, 2026, and classified as Class II by the US Food and Drug Administration (FDA) on October 13. The classification means exposure to the affected product may cause temporary or medically reversible health consequences, while the probability of serious harm is considered remote.
The recall covers two batches: LB00047A and LB00048A, both with an expiry date of March 2028. Available reports have not identified the specific impurity involved or disclosed its concentration.
Hydrocortisone sodium succinate is an injectable corticosteroid used in the management of several serious conditions, including acute adrenal insufficiency, severe allergic reactions and inflammatory disorders when oral medication cannot be administered or is unsuitable.
The recall highlights the importance of stringent pharmaceutical quality controls, particularly for injectable medicines, where product quality and purity are critical. While the FDA’s Class II designation indicates a lower likelihood of serious harm than a Class I recall, it still signals a potential quality concern requiring appropriate corrective action.
Written by: Pramit Hazra
Graphics by: Pramit Hazra
