Quality & complianceOfficial

FDA classifies Zydus hydrocortisone sodium succinate injection recall as Class II over impurity failures

🇺🇸 FDA enforcement report · Wed 21 Oct 2026

The recall of Zydus Pharmaceuticals (USA) Inc's hydrocortisone sodium succinate for injection, logged as D-0039-2027, is ongoing and covers nationwide distribution within the United States.

The US Food and Drug Administration has published a Class II recall in its enforcement report for Hydrocortisone Sodium Succinate for Injection, marketed by Zydus Pharmaceuticals (USA) Inc. The report is dated 21 October 2026.

The recall is listed under number D-0039-2027. The stated reason is that the product failed impurities and degradation specifications.

The FDA lists the recall status as ongoing. Distribution is described as nationwide within the United States.

The page text available to VigiEye contained only search-tool navigation and no detailed entry. It gave no lot numbers, expiry dates, quantities, strengths or the date the recall began, so those details could not be reported here.

For context, the FDA applies a Class II designation where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

What it means for your team

  • Quality teams should check whether any hydrocortisone sodium succinate for injection in their supply chain comes from Zydus and compare it against the full FDA enforcement report entry for D-0039-2027.
  • The reason, failure of impurities and degradation specifications, is a stability and quality-control issue that may be relevant to wider review of impurity limits for injectable products.
  • Because the recall is ongoing and nationwide in the US, supply and market-access teams may want to monitor for shortages or substitution needs, although the source gives no supply information.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

More Quality & compliance All →