Class II · Moderate risk
Tobramycin for Injection
Failed Stability Specification: Water determination was found not complying with specification.
Is Tobramycin recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Tobramycin (27 total). Check the affected lots below.
Most common reason: Sterility / contamination (16 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tobramycin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Tobramycin recalls on record
none so far in 2026; 27 on record, newest first
Class III · Low risk
Tobramycin Opthalmic Solution USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Tobramycin Inhalation Solution USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Tobramycin 660mg in Ns 66ml
Lack of sterility assurance
Class II · Moderate risk
Tobramycin Fortified 15mg/Ml Oph Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
TobraDex (tobramycin and dexamethasone)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Tobramycin Irrigation 80 mg/1000 mL Solution
Lack of Processing Controls
Class II · Moderate risk
Tobramycin 14 mg/mL Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Tobramycin 15mg/mL Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Tobramycin 620 mg/NS 100 mL Accuflo
Lack of Assurance of Sterility
Class II · Moderate risk
Tobramycin 120MG
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Tobramycin 14 mg/mL Ophthalmic Solution
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Fortifed Tobramycin 15 mg/1 mL Opth.
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Tobramycin various strengths in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Tobramycin Sulfate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Tobramycin Base active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Tobramycin
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection
Class II · Moderate risk
Tobramycin
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Tobramycin 300 mg/7.5 mL Syringe
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Class II · Moderate risk
Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Tobramycin Opth Soln 13mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Tobramycin Opth Soln 14mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
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