Class III · Low risk
Tobramycin Ophthalmic Oint.
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Is Tobramycin recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Tobramycin (27 total). Check the affected lots below.
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 II · Moderate risk
Tobramycin 1.4%
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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