HIGH

Major Pharmaceuticals Recalls Prescription Medication Over Contamination Risk

Major Pharmaceuticals recalled Sulfamethoxazole and Trimethoprim tablets on September 2, 2025, due to contamination concerns. A foreign substance was found in the packaging material, although the tablets themselves remain unaffected. Consumers should stop using the product immediately and consult healthcare providers.

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 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your healthcare provider for guidance. Notification method: Letter

Product Details

The recall involves Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, in blister packs containing 100 tablets. The affected lot is Lot # N02309, with an expiration date of March 31, 2027.

The Hazard

The recall stems from the detection of a micro-organism in a specific lot of polyester coil used for product packaging. No micro-organism was found on the tablets themselves.

Reported Incidents

There have been no reported incidents of illness or injury linked to this product. The risk remains elevated due to the potential for contamination.

What to Do

Consumers should stop using the medication immediately. Contact The Harvard Drug Group LLC or your healthcare provider for guidance.

Contact Information

For more information, consumers can visit the recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0624-2025.

Key Facts

  • Recall date: September 2, 2025
  • Report date: September 17, 2025
  • Affected lot: N02309
  • Expiration date: 03/31/2027
  • No micro-organisms detected on tablets
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot # N02309
Exp 03/31/2027
UPC Codes
0904-2725
0904-2725-61
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE
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