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

Is NDC 47335-0779-91 recalled?

Azelastine Hydrochloride · 1 BOTTLE, SPRAY in 1 BOX (47335-779-91) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY

Yes — this exact package was recalled

1 FDA recall names the code 47335-0779-91 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
Azelastine Hydrochloride
Strength
AZELASTINE HYDROCHLORIDE 137 ug/1
Form
Spray, Metered · Nasal
Labeler
Sun Pharmaceutical Industries, Inc.
Type
Human Prescription Drug
Product code
47335-0779

Recalls naming this package

Class III ยท Low risk

Azelastine HCl Nasal Solution

Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station

Terminated Stability / shelf life Sun Pharmaceutical Industries, Inc. NDC 47335-779-91 D-0417-2018

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