Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Is Polymyxin B recalled?
Yes — there is an active recall. 9 ongoing FDA recalls mention Polymyxin B (21 total). Check the affected lots below.
Most common reason: cGMP deviation (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Polymyxin B. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Polymyxin B recalls in 2026
5 initiated in 2026, 21 in total — newest first
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
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment
cGMP deviations: Temperature abuse
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class III · Low risk
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension
Labeling: Incorrect or missing package insert.
Class II · Moderate risk
Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class II · Moderate risk
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone…
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class II · Moderate risk
Polycin (bacitracin zinc and polymyxin B sulfate)
Lack of Assurance of Sterility
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 II · Moderate risk
Neomycin / Polymyxin / Dexamethasone Ophthalmic Drops
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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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