Class II · Moderate risk
Gentamicin Injection
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Is Gentamicin recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Gentamicin (40 total). Check the affected lots below.
Most common reason: Sterility / contamination (29 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Gentamicin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Gentamicin recalls on record
none so far in 2026; 40 on record, newest first
Class II · Moderate risk
Gentamicin Bladder 0.08mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Gentamicin Sulfate Cream USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Gentamicin Sulfate Ointment USP 0.1%
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Gentamicin Sulfate Cream USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Gentamicin 80mg/60 mL Irrigation
Lack of Assurance of Sterility
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
Sodium Citrate 40 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
S-Gentamicin 480mg/1l
Lack of Assurance of Sterility
Class II · Moderate risk
C-Gentamicin 30mg/Ml Inj Solution Sdv
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
Gentamicin
Lack of Processing Controls
Class II · Moderate risk
Gentamicin 240 mg/500 mL Sterile Water for Irrigation
Lack of sterility assurance.
Class II · Moderate risk
Gentamicin 160 mg/1000 mL Sterile Water for Irrigation
Lack of sterility assurance.
Class II · Moderate risk
Gentamicin 250 mg/1000 mL Irrigation
Lack of sterility assurance.
Class II · Moderate risk
Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation
Lack of sterility assurance.
Class II · Moderate risk
Gentamicin Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Class II · Moderate risk
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Class II · Moderate risk
Gentamicin Sulfate Ophthalmic Solution
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Class II · Moderate risk
Gentamicin Sulfate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
GENTAMICIN 15 MG/ML Ophthalmic Solution
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Gentamicin
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Gentamicin Sulfate
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
GENTAMICIN 14.4 mg / NS 30 mL SYRINGE
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Gentamicin various strength in normal saline bags
Lack of sterility assurance.
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