HIGH

Northwind Pharmaceuticals Recalls Sulfamethoxazole Tablets Due to Contamination Risk

Northwind Pharmaceuticals recalled Sulfamethoxazole and Trimethoprim Tablets on August 20, 2025. The recall affects several lot numbers due to a foreign substance found in packaging. Consumers should stop using the product and seek guidance immediately.

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

Product Details

The recall includes Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength. Affected packaging includes 6-count (NDC 51655-307-87), 10-count (NDC 51655-307-53), 14-count (NDC 51655-307-84), and 20-count bottles (NDC 51655-307-20). A total of 2,295 bottles are recalled.

The Hazard

The recall was initiated due to the detection of a micro-organism on a specific lot of auxiliary polyester coil used in product packaging. No micro-organism was detected on any of the tablets themselves.

Reported Incidents

There have been no reported injuries or incidents associated with the contaminated product. The presence of the micro-organism poses a high risk to consumer safety.

What to Do

Consumers and healthcare providers should immediately stop using the recalled product. Contact Northwind Pharmaceuticals LLC or consult a healthcare provider for further guidance.

Contact Information

For more information, contact Northwind Pharmaceuticals at their official website or through the FDA recall link.

Key Facts

  • Recalled product: Sulfamethoxazole and Trimethoprim Tablets
  • Recalled on: August 20, 2025
  • Total recalled: 2,295 bottles
  • No micro-organism detected on tablets
  • High risk to consumer safety

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 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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