Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.07%
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Is Bromfenac recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Bromfenac (15 total). Check the affected lots below.
Most common reason: Sterility / contamination (8 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bromfenac. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Bromfenac recalls in 2026
1 initiated in 2026, 15 in total — newest first
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Class III · Low risk
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09% 1.7ml Ndc/Upc 62332-508-17
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
BromSite (bromfenac ophthalmic solution)
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Bromfenac Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Bromfenac
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Lack of Assurance of Sterility: Failed preservative effectiveness test
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Class II · Moderate risk
Bromfenac Ophthalmic Solution
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Class III · Low risk
Bromfenac Ophthalmic Solution 0.09%
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Class II · Moderate risk
Bromfenac Sodium 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.
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