Class II · Moderate risk
Moxifloxacin 0.1% in BSS
Lack of Assurance of Sterility
Is Moxifloxacin recalled?
Yes — there is an active recall. 14 ongoing FDA recalls mention Moxifloxacin (38 total). Check the affected lots below.
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
Prednisolone 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.5% Ophth Solution Syringe
Lack of Assurance of Sterility
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Class II · Moderate risk
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%
Lack of sterility assurance.
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Class II · Moderate risk
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Moxifloxacin HCl 1 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.5% + Dexamethazone 0.1%
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin HCl 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
VIGAMOX (moxifloxacin)
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
Moxifloxacin 150mcg/0.1ml
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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