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

Is NDC 53489-0146-01 recalled?

Sulfamethoxazole and Trimethoprim · 100 TABLET in 1 BOTTLE, PLASTIC (53489-146-01)

Yes — this exact package was recalled

1 FDA recall names the code 53489-0146-01 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
Sulfamethoxazole and Trimethoprim
Strength
SULFAMETHOXAZOLE 800 mg/1; TRIMETHOPRIM 160 mg/1
Form
Tablet · Oral
Labeler
Sun Pharmaceutical Industries, Inc.
Type
Human Prescription Drug
Product code
53489-0146

Recalls naming this package

Class II · Moderate risk

Sulfamethoxazole and Trimethoprim Tablets USP

Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.

Terminated Particulate / foreign matter Sun Pharmaceutical Industries, Inc. NDC 53489-146-05 D-0802-2018

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