Zydus Recalls 70,776 Vials of Anti-Inflammatory Drug Hydrocortisone in US
New Delhi: Zydus Pharmaceuticals (USA) Inc. has initiated a voluntary recall of 70,776 vials of Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, after the product failed to meet impurity and degradation specifications.
The affected product was manufactured by Zydus Lifesciences Ltd. at its facility in Vadodara, Gujarat, India, and distributed by Zydus Pharmaceuticals (USA) Inc., based in Pennington, New Jersey.
The recall was initiated on October 1, 2026, and classified as a Class II recall on October 13, 2026. Under this classification, the use of the affected product may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences is considered remote.
The recall affects lot numbers LB00047A and LB00048A, with an expiry date of March 2028. The product was distributed nationwide across the United States, and the recall remains ongoing.
Hydrocortisone Sodium Succinate is an injectable glucocorticoid indicated for acute adrenal insufficiency, severe allergic reactions, rheumatic disorders, and other inflammatory or immune-mediated conditions when oral therapy is not feasible.
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