Quick Facts at a Glance
- Recall Date
- September 2, 2025
- Hazard Level
- HIGH
- Brand
- Sulfamethoxazole and Trimethoprim
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Sulfamethoxazole and Trimethoprim
- Product type
- Oral Antibiotic Tablet
- Model numbers
- Lot N02309, Exp 03/31/2027
- UPC codes
- 0904-2725, 0904-2725-61
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 2, 2025
Reported by FDA DRUG
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
This medication is a commonly prescribed antibiotic used to treat bacterial infections. The product comes in 800 mg/160 mg double-strength tablets and is Rx only.
Why This Is Dangerous
The hazard involves a foreign substance in packaging materials. A microorganism was detected in the auxiliary polyester coil used in packaging. The tablets themselves tested negative for microorganisms.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall may cause temporary treatment delays for patients who were prescribed this antibiotic. Consumers should discontinue use and seek guidance from a clinician.
Practical Guidance
How to identify if yours is affected
- Check the NDC 0904-2725-61 on your bottle
- Review the carton for Lot N02309 and Exp 03/31/2027
- Confirm packaging coil origin from Amneal Pharmaceuticals LLC
Where to find product info
Recall notices and supplier statements should be available from Major Pharmaceuticals and the FDA enforcement database (D-0624-2025)
What timeline to expect
Recall processing outcomes and refunds or replacements, if offered, will follow the company’s recall procedure
If the manufacturer is unresponsive
- Document all communications with the supplier
- Consider contacting a healthcare provider or pharmacist for guidance
- File a consumer product incident report with CPSC if you believe there is broader risk
How to prevent similar issues
- Check NDC and lot numbers before taking any prescription medication
- Follow recall notices promptly
- Consult your healthcare provider before switching antibiotics
Documentation advice
Keep the recall letter, packaging, and any correspondence with the supplier for records
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Product Details
Product: Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg double-strength, 100 tablets per carton, unit-dose blister packs (10x10). Rx only. NDC 0904-2725-61. Distributor: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Packaged by Amneal Pharmaceuticals LLC. Sold nationwide in the USA. Recall date: 2025-09-02. Report date: 2025-09-17. Lot: N02309. Expiration: 03/31/2027.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 100 tablets per carton
- Unit-dose blister packs (10x10)
- Packaged by Amneal Pharmaceuticals LLC (packaging coil)
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Safety Guide
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