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Drug FDA Class II Ongoing Contamination / non-sterility

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Published Sep 17, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

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 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Hazards

Microbial contamination in packaging material · primary

Affected products (1)

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).

SULFAMETHOXAZOLE AND TRIMETHOPRIM · N/A

NDC: 55154-7895, 0904-2725, 55154-7895-0, 0904-2725-61
Lot codes: N02309
Code info: Bag: N02309A and N02309B, Exp Date: 03/31/2027; Inner blister: Lot # N02309, Exp Date: 03/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 2, 2025
  2. Published
    Sep 17, 2025
Recall number
D-0625-2025
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.