Class II · Moderate risk
Tri-Moxi+¿
Presence of particulate matter - Glass like particles.
Is Moxifloxacin recalled?
Yes — there is an active recall. 14 ongoing FDA recalls mention Moxifloxacin (38 total). Check the affected lots below.
Most common reason: Sterility / contamination (20 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Moxifloxacin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Moxifloxacin recalls on record
none so far in 2026; 38 on record, newest first
Class II · Moderate risk
Dexamethasone Moxifloxacin Ketorolac
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Dexamethasone Moxifloxacin
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials…
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use…
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone-Moxifloxacin- Ketorolac
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone-Moxifloxacin
Lack of Assurance of Sterility
Class II · Moderate risk
Class II · Moderate risk
Moxifloxacin 5mg/ml
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Moxifloxacin PF
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin in Balanced Salt Solution
Lack of Assurance of Sterility
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
Moxifloxacin HCl Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Moxifloxacin Preservative Free Syr
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution USP 0.5%
Failed impurities/degradation specifications
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Moxifloxacin
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Class II · Moderate risk
Dexamethasone - Moxifloxacin PF Injection
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Class II · Moderate risk
Moxifloxacin 0.1% in BSS
Lack of Assurance of Sterility
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