Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Is Bacitracin recalled?
Yes — there is an active recall. 13 ongoing FDA recalls mention Bacitracin (25 total). Check the affected lots below.
Most common reason: cGMP deviation (12 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bacitracin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Bacitracin recalls in 2026
9 initiated in 2026, 25 in total — newest first
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Rapidol
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lil Drug Store
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Circle K
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lucky Super Soft
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Rapidol
CGMP Deviations
Class II · Moderate risk
Neomycin & Polymyxin B Sulfates
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ak-Poly-Bac
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Neomycin and Polymyxin B Sulfates
CGMP Deviations:
Class II · Moderate risk
Class II · Moderate risk
Triple Antibiotic Ointment
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Perrigo Bacitracin Ophthalmic Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Polycin (bacitracin zinc and polymyxin B sulfate)
Lack of Assurance of Sterility
Class II · Moderate risk
Perrigo Sterile Neo-Polycin HC
Lack of Assurance of Sterility
Class II · Moderate risk
Perrigo Neo-Polycin neomycin and polymixin B sulfates and…
Lack of Assurance of Sterility
Class II · Moderate risk
Bacitracin 3000U/30 mL Irrigation
Lack of sterility assurance.
Class II · Moderate risk
CVS Health
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Class II · Moderate risk
Rite Aid Pharmacy
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Class II · Moderate risk
Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class III · Low risk
Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units
Failed Stability Specifications: Unable to meet shelf life expiry.
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