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

Is NDC 68462-0185-56 recalled?

fluocinolone acetonide · 1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER

Yes — this exact package was recalled

1 FDA recall names the code 68462-0185-56 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.

Active ingredient
fluocinolone acetonide
Strength
FLUOCINOLONE ACETONIDE .11 mg/mL
Form
Oil · Auricular (otic)
Labeler
Glenmark Pharmaceuticals Inc., USA
Type
Human Prescription Drug
Product code
68462-0185

Recalls naming this package

Class II · Moderate risk

Fluocinolone Acetonide Oil

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Terminated Failed specification Glenmark Pharmaceuticals Inc., USA NDC 68462-185-56 D-0259-2024

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