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
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, Northwind Pharmaceuticals
- Product type
- Sulfamethoxazole and Trimethoprim Tablets
- 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, Lot #: F118062512, Exp. Date 04/30/2027, Lot #: F118062506, Exp. Date 06/30/2027, Lot #: F118062423, Exp. Date 01/31/2027 +3 more
- UPC codes
- 51655-307, 51655-307-20, 51655-307-29, 51655-307-53, 51655-307-84, 51655-307-87
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 20, 2025
Reported by FDA DRUG
September 24, 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 Northwind Pharmaceuticals LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
Sulfamethoxazole and Trimethoprim are antibiotics used to treat various bacterial infections. Consumers buy this product for conditions like urinary tract infections and respiratory infections as it is effective against specific bacteria.
Why This Is Dangerous
The hazard stems from a micro-organism detected in the packaging material, which poses a contamination risk. Although the tablets themselves were not contaminated, consumers should stop using the product to avoid any potential health risks linked to the packaging.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects consumers who rely on this medication for treatment. They may face interruptions in their treatment while seeking alternatives or awaiting refunds, which could impact their health.
Practical Guidance
How to identify if yours is affected
- Locate the lot number on your bottle of Sulfamethoxazole and Trimethoprim.
- Verify if your lot number matches any of the recalled numbers listed in the recall notice.
- Check expiration dates to see if your product is within the recalled lots.
Where to find product info
You can find the lot number printed on the label or the packaging of the medication, typically near the expiration date.
What timeline to expect
Allow 4-6 weeks for processing refunds or replacements after contacting Northwind Pharmaceuticals.
If the manufacturer is unresponsive
- Reach out again to Northwind Pharmaceuticals with your concerns.
- Document your attempts to get a response and consider reporting to FDA if still no response.
How to prevent similar issues
- Always check for recalls before using medications.
- Pay attention to any changes in packaging or labels when receiving medication from the pharmacy.
- Consult with healthcare providers for alternative treatments if needed.
Documentation advice
Keep a record of your purchase receipt, correspondence with the manufacturer, and any notifications received regarding the recall.
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Product Details
Recalled products include Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength. Packaged in 6-count, 10-count, 14-count, and 20-count bottles. Lot numbers include F118062503, F118062507, and other specified lots. Distributed nationwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 2,295 total bottles recalled
- Includes 96 bottles (6-count), 627 bottles (10-count), 428 bottles (14-count), 1,144 bottles (20-001
- Expirations dates range from 01/31/2027 to 08/31/2027
- Contact Northwind Pharmaceuticals for refund instructions
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Safety Guide
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