Hydrocortisone Injection Recalled Due to the Failed Impurities Specifications
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for hydrocortisone sodium succinate injection, USP, 100 mg/vial. The affected batches have been identified as Lots LB00047A and LB00048A (expire March 2028), containing 70 776 vials.
- The recall was initiated by Zydus Pharmaceuticals (USA), Inc due to the product’s failure to meet impurities specifications, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
- Hydrocortisone is used to treat a variety of conditions.
The FDA has issued a Class II recall for hydrocortisone sodium succinate injection, USP, 100 mg/vial, affecting 70 776 vials. This product is being recalled by Zydus Pharmaceuticals (USA), Inc based in Pennington, New Jersey. The recall was initiated on October 1, 2026, and received a Class II classification on October 13, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
The recall was initiated after the product failed to meet impurities specifications. This issue affects Lots LB00047A and LB00048A, which will expire in March 2028. Zydus Pharmaceuticals sent out a public notice via letter; no press release was issued for this recall.
Hydrocortisone is used to treat various conditions, including inflammation, severe allergic reactions, kidney diseases, arthritis, asthma, lupus, and ulcerative colitis. It can also be used to treat conditions affecting the blood, eyes, skin, and nervous system. Pharmacists should identify and quarantine Lots LB00047A and LB00048A, remove them from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. October 21, 2026. Accessed October 21, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=223153
