Quick Facts at a Glance
- Recall Date
- September 2, 2025
- Hazard Level
- HIGH
- Brands
- SULFAMETHOXAZOLE AND TRIMETHOPRIM, Cardinal Health, Major Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
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, Cardinal Health, Major Pharmaceuticals
- Product type
- Antibiotic Suspension Tablets (Sulfamethoxazole and Trimethoprim)
- Model numbers
- Bag: N02309A, Bag: N02309B, Inner blister: Lot N02309
- UPC codes
- 55154-7895, 0904-2725, 55154-7895-0, 0904-2725-61
- Sizes
- 10 tablets per blister, per bag
- Sold at
- Unknown
- 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 antibiotic combines sulfamethoxazole and trimethoprim for bacterial infections. It is used under medical supervision and is distributed nationwide.
Why This Is Dangerous
A foreign-substance material in packaging raises contamination concerns. No tablets were contaminated.
Industry Context
This recall is not part of a broader industry recall pattern.
Real-World Impact
Immediate stop-use is required; potential supply disruption for patients needing antibiotics.
Practical Guidance
How to identify if yours is affected
- Check outer bag NDC 55154-7895-0
- Check inner blister NDC 0904-2725-61
- Look for lot N02309 on tablets or packaging
- Bag IDs N02309A/N02309B
- Verify packaging material vs tablets
Where to find product info
FDA enforcement recall page D-0625-2025 and FDA enforcement report with recall number D-0625-2025
What timeline to expect
Remedy delivery via recall notification letters; refunds/replacements governed by distributor policies
If the manufacturer is unresponsive
- Escalate to FDA recall contact
- Consider consumer protection agencies if needed
How to prevent similar issues
- Use authentic suppliers
- Verify lot numbers before distribution
- Maintain packaging integrity checks on received medicines
Documentation advice
Keep recall notice, take photos of packaging and lot numbers, note dates of receipt
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Product Details
Product: Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg double strength, 10 tablets per blister pack (10x1) per bag. Distributors: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Distributed by Cardinal Health, Dublin, OH 43017. NDC: 55154-7895-0. Outer bag contains NDC 0904-2725-61 in inner blisters. Lot: N02309. Bag identifiers: Bag N02309A and N02309B.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide distribution in the USA
- Active recall dated 2025-09-02
- High hazard level
- Lot N02309 with bag identifiers N02309A/N02309B
- Inner blister lot N02309
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Safety Guide
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