Regulatory UpdatesAug 24, 2026•1 min read

FDA Recalls All Compounded Sterile Preparations Due to Sterility Assurance Issues

By the PharmaCountry team

The FDA is initiating a recall of all compounded sterile preparations still within their expiration dates because poor sterile production practices have compromised sterility assurance.

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#sterile compounding #recall #FDA #sterility assurance #pharmaceutical manufacturing