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# Bacitracin Withdrawn Due to Safety: FDA
- URL: https://www.fdaweb.com/bacitracin-withdrawn-due-to-safety-fda/
- Published: 2022-09-15T12:00:00.000Z
- Updated: 2026-09-14T17:59:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152742

*Federal Register* notice: FDA has determined that intramuscular antibiotic bacitracin for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn due to safety or effectiveness reasons. Such a finding requires the agency to not accept or approve ANDAs (XXX PLURAL XXX)for the drug product. In 2019, FDA’s Antimicrobial Drugs Advisory Committee advised that the benefits of bacitracin for injection do not outweigh its risks, such as nephrotoxicity and anaphylactic reactions. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-09-15/pdf/2022-19995.pdf?ref=fdaweb.com).