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

Is NDC 55319-0835-01 recalled?

Family Wellness Earwax Removal Earwax and Bulb · 1 KIT in 1 KIT (55319-835-01) * 1 PACKAGE in 1 BOX (55319-836-01) / 15 mL in 1 PACKAGE

Yes — this exact package was recalled

1 FDA recall names the code 55319-0835-01 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.

1 of these recalls is still ongoing.

Active ingredient
Carbamide Peroxide
Form
Kit
Labeler
Family Dollar Services Inc
Type
Human OTC Drug
Product code
55319-0835

Recalls naming this package

Class II · Moderate risk

FAMILY Wellness

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Ongoing Wrong potency / content Bell Pharmaceuticals, Inc NDC 55319-835-01 D-0683-2026

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