Quick Facts at a Glance
- Recall Date
- August 18, 2025
- Hazard Level
- HIGH
- Brands
- SULFAMETHOXAZOLE AND TRIMETHOPRIM, Amneal Pharmaceuticals LLC
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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, Amneal Pharmaceuticals LLC
- Product type
- Antibiotic Tablets
- Model numbers
- AM240173, AM240176, AM240177, AM240301, AM240300, AM240676, AM240677, AM240678 +5 more
- UPC codes
- 65162-271, 65162-272, 65162-271-05, 65162-271-10, 65162-271-50, 65162-271-11, 65162-272-01, 65162-272-24 +3 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 18, 2025
Reported by FDA DRUG
September 10, 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 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 Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
This antibiotic is used to treat bacterial infections. The double-strength tablet is prescribed for specific infections and dosages per clinician instruction.
Why This Is Dangerous
A foreign packaging material fragment could contaminate the product packaging. Although no tablets were found contaminated, the potential risk warrants withdrawal from distribution.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
Consumers may face interruption of antibiotic therapy and potential need for replacement at healthcare provider's guidance.
Practical Guidance
How to identify if yours is affected
- Confirm packaging is from Amneal Pharmaceuticals
Where to find product info
Label on bottle shows NDC and lot number. FDA recall notice provides lot and bottle size details.
What timeline to expect
Refunds or replacements will be arranged after recall notification by mail. Expect several weeks to process.
If the manufacturer is unresponsive
- File a consumer complaint with the FDA
- Consult healthcare provider for safe alternative therapy
How to prevent similar issues
- Always verify NDC and lot numbers before consuming any medication
- Prefer purchases from reputable pharmacies with clear recall notices
- Register prescription medications at the manufacturer’s portal if available
Documentation advice
Save recall notice, take photographs of the bottle label, and keep all correspondence with the pharmacy and manufacturer
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Product Details
Product: Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg Double Strength. Packaging: 100-count bottle (NDC 65162-272-10) and 500-count bottle (NDC 65162-272-50). Manufacturer: Amneal Pharmaceuticals Pvt. Ltd, Ahmedabad, India. Distributor: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Lots involved: AM240173, AM240176, AM240177, AM240301, AM240300, AM240676, AM240677, AM240678, AM240679, AM240680, AM240921, AM240922, AM240923. Quantity recalled: 60,072 (100-count) and 73,054 (500-count). Distribution: Nationwide in the USA. Recall date: 2025-08-18. Report date: 2025-09-10.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 60,072 100-count bottles recalled
- 73,054 500-count bottles recalled
- AM240680, AM240921, AM240922, AM240923
- Packaging polyester coil associated with micro-organism detected
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Safety Guide
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