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Drug FDA Class I Ongoing Contamination / non-sterility

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceutica

Amneal Pharmaceuticals, LLC Published Jun 18, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Amneal Pharmaceuticals, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

Hazards

Microbial contamination · primary

Affected products (1)

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

SULFAMETHOXAZOLE AND TRIMETHOPRIM · 6396 bottles

NDC: 65162-271, 65162-272, 65162-271-05, 65162-271-10, 65162-271-50, 65162-271-11, 65162-272-01, 65162-272-24, 65162-272-10, 65162-272-25, 65162-272-50
Code info: Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 2, 2025
  2. Published
    Jun 18, 2025
Recall number
D-0488-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.