Class II · Moderate risk
Ofloxacin Ophthalmic Solution
CGMP Deviations:
Is Ofloxacin recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Ofloxacin (9 total). Check the affected lots below.
Most common reason: Sterility / contamination (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ofloxacin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Ofloxacin recalls on record
none so far in 2026; 9 on record, newest first
Class II · Moderate risk
Ofloxacin Otic Solution 0.3%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ofloxacin 0.3% 5ml Opth
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ofloxacin Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln + Tetracaine
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Ofloxacin active pharmaceutical ingredient packaged in varying…
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 III · Low risk
Ofloxacin Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Ofloxacin Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
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