Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0023-0316-04 recalled?

FML (fluorometholone ophthalmic ointment)

Yes — this exact package was recalled

1 FDA recall names the code 0023-0316-04 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.

Recalls naming this package

Class II · Moderate risk

FML (fluorometholone ophthalmic ointment)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Terminated Particulate / foreign matter Allergan Sales, LLC NDC 0023-0316-04 D-1819-2015

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler