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# FDA Seeks Bacitracin for Injection Market Withdrawal
- URL: https://www.fdaweb.com/fda-seeks-bacitracin-for-injection-market-withdrawal/
- Published: 2020-01-31T12:00:00.000Z
- Updated: 2026-09-14T16:01:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145985

FDA is requesting that all bacitracin for injection manufacturers voluntarily withdraw their product from the market because the benefits no longer outweigh safety concerns. Bacitracin for injection is currently approved for treating infants with pneumonia and empyema (a collection of pus in the space between the membranes lining the lungs) caused by staphylococci. “However, health care professionals no longer use bacitracin for injection to treat this condition because other effective FDA-approved treatments are available that do not have the same serious risks, including nephrotoxicity (harm to the kidneys), anaphylactic reactions and the need for repeated intramuscular injections,” an [FDA notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market?ref=fdaweb.com) says.  

Last April, the agency’s Antimicrobial Drugs Advisory Committee met and discussed the drug’s safety and effectiveness ([see minutes of the meeting](https://www.fda.gov/media/127630/download?ref=fdaweb.com)). Panel members noted that there is no evidence of current use for its labeled indication and a lack of susceptibility criteria (breakpoints) to guide clinicians. Many members also cited the lack of recommendations from professional medical and surgical societies supporting the use of bacitracin for intramuscular injection for either its labeled indication or for off-label uses.