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

Is NDC 13107-0046-01 recalled?

Oxycodone and Acetaminophen · 100 TABLET in 1 BOTTLE (13107-046-01)

Yes — this exact package was recalled

1 FDA recall names the code 13107-0046-01 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.

Active ingredient
Oxycodone and Acetaminophen
Strength
OXYCODONE HYDROCHLORIDE 10 mg/1; ACETAMINOPHEN 325 mg/1
Form
Tablet · Oral
Labeler
Aurolife Pharma, LLC
Type
Human Prescription Drug · DEA CII
Product code
13107-0046

Recalls naming this package

Class II · Moderate risk

Oxycodone and Acetaminophen Tablets

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Terminated Packaging defect Aurobindo Pharma USA Inc. NDC 13107-046-01 D-1237-2020

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