HIGH

96 Bottles of Sulfamethoxazole and Trimethoprim Tablets Recalled for Micro-Organism Contamination

Northwind Pharmaceuticals recalled 2,295 bottles of Sulfamethoxazole and Trimethoprim Tablets due to contamination risks. A foreign substance was detected in the packaging's auxiliary polyester coil, although no micro-organisms were found on the tablets. Consumers should stop using these products immediately and contact Northwind Pharmaceuticals for guidance.

Quick Facts at a Glance

Recall Date
August 20, 2025
Hazard Level
HIGH
Brands
SULFAMETHOXAZOLE AND TRIMETHOPRIM, Northwind Pharmaceuticals
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Northwind Pharmaceuticals LLC or your healthcare provider for guidance. Notification method: Letter

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About This Product

Sulfamethoxazole and Trimethoprim are antibiotics used to treat various bacterial infections. Consumers buy this product for conditions like urinary tract infections and respiratory infections as it is effective against specific bacteria.

Why This Is Dangerous

The hazard stems from a micro-organism detected in the packaging material, which poses a contamination risk. Although the tablets themselves were not contaminated, consumers should stop using the product to avoid any potential health risks linked to the packaging.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects consumers who rely on this medication for treatment. They may face interruptions in their treatment while seeking alternatives or awaiting refunds, which could impact their health.

Practical Guidance

How to identify if yours is affected

  1. Locate the lot number on your bottle of Sulfamethoxazole and Trimethoprim.
  2. Verify if your lot number matches any of the recalled numbers listed in the recall notice.
  3. Check expiration dates to see if your product is within the recalled lots.

Where to find product info

You can find the lot number printed on the label or the packaging of the medication, typically near the expiration date.

What timeline to expect

Allow 4-6 weeks for processing refunds or replacements after contacting Northwind Pharmaceuticals.

If the manufacturer is unresponsive

  • Reach out again to Northwind Pharmaceuticals with your concerns.
  • Document your attempts to get a response and consider reporting to FDA if still no response.

How to prevent similar issues

  • Always check for recalls before using medications.
  • Pay attention to any changes in packaging or labels when receiving medication from the pharmacy.
  • Consult with healthcare providers for alternative treatments if needed.

Documentation advice

Keep a record of your purchase receipt, correspondence with the manufacturer, and any notifications received regarding the recall.

Product Details

Recalled products include Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength. Packaged in 6-count, 10-count, 14-count, and 20-count bottles. Lot numbers include F118062503, F118062507, and other specified lots. Distributed nationwide.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 2,295 total bottles recalled
  • Includes 96 bottles (6-count), 627 bottles (10-count), 428 bottles (14-count), 1,144 bottles (20-001
  • Lot numbers F118062503, F118062507, F118062504, F118062505, F118062509, F118062512, F118062506, F118
  • Expirations dates range from 01/31/2027 to 08/31/2027
  • Contact Northwind Pharmaceuticals for refund instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
5/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeSulfamethoxazole and Trimethoprim Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot #: F118062503, Exp Date 05/31/2027
Lot #: F118062507, Exp Date 07/31/2027
Lot #: F118062504
Lot #: F118062505, Exp. Date 05/31/2027
Lot #: F118062509, Exp. Date 08/31/2027
+6 more
UPC Codes
51655-307
51655-307-20
51655-307-29
+3 more
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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