SULFAMETHOXAZOLE AND TRIMETHOPRIM
Recalling Firm / Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
(La Vergne, TN, United States)
FDA Recall Number: D-0624-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Generic Name
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Active Substance(s)
Sulfamethoxazole, Trimethoprim
Administration Route
Oral
National Drug Code (NDC)
0904-2725
Total Quantity Recalled
N/A
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
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.
Full Product Description
Packaging specifications and labeling details
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
September 17, 2025
Firm Initiation Date
September 02, 2025
FDA Classification Date
Sep 10, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # N02309, Exp 03/31/2027
Distribution Information
Geographic scope of affected shipments
USA Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0624-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508613UTCC