# Major Recall Alert: Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg Recalled Due to Microbial Contamination
Amneal Pharmaceuticals LLC has issued a **nationwide recall** of its Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg due to potential **microbial contamination**. This serious issue could pose significant health risks, particularly for patients with weakened immune systems. Here’s everything you need to know about this recall, who it impacts, and what you should do.
## Why This Recall is Important
Amneal’s recall applies to three specific lots of Sulfamethoxazole/Trimethoprim Tablets that may have **black spots on the surface**, indicating microbial contamination. Testing revealed the presence of *Aspergillus*, a fungus that can cause **severe infections**, especially in immunocompromised individuals. While no adverse events or injuries have been reported to date, taking contaminated medication could lead to **life-threatening risks** for certain users.
This recalled product is widely prescribed for the treatment of several bacterial infections, such as:
- **Urinary Tract Infections (UTIs)** caused by *Escherichia coli*, *Klebsiella species*, and others.
- **Acute Otitis Media** in pediatric patients.
- **Acute Exacerbations of Chronic Bronchitis** caused by *Streptococcus pneumoniae*.
- **Traveler’s Diarrhea** in adults.
- **Enteritis** caused by *Shigella flexneri*.
Given the medication’s nationwide distribution and critical use in treating infections, the recall highlights serious concerns for public health.
## Details of the Recall
Here are the key facts regarding the recalled product:
- **Product Name**: Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg
- **Manufacturer**: Amneal Pharmaceuticals LLC
- **Reason for Recall**: Microbial contamination (*Aspergillus*) potentially causing black spots on tablets.
- **Affected Lot Numbers**: Only specific lots are impacted; check the bottle label or pharmacy vial for lot information.
- **Distribution Dates**: December 4, 2024, through May 15, 2025.
- **Packaging Sizes**: 100-tablet and 500-tablet bottles.
This recall affects **only the 400 mg/80 mg strength**. No other dosages, medications, or lots are currently impacted.
To learn more, visit the **[official FDA recall notification](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-sulfamethoxazole-trimethoprim-tablets-usp-400).**
## What You Should Do
If you have this medication at home, here’s what to do next:
- **Check the lot number**: Confirm whether your product matches the lots affected by this recall. If unsure, check with your pharmacist.
- **Stop using the product**: Discontinue use of the affected tablets immediately.
- **Contact Amneal Pharmaceuticals**: For assistance with product returns and reimbursement, reach out to Amneal through:
- **Phone**: 1-877-835-5472 (Monday – Friday, 8:00 AM – 6:00 PM EST)
- **Email**: DrugSafety@amneal.com
Additionally, adverse reactions or quality issues can be reported to the FDA through their **MedWatch Adverse Event Reporting Program** by visiting [FDA MedWatch](https://www.fda.gov/safety/medwatch).
## Stay Safe – Get Instant Recall Alerts
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Amneal Pharmaceuticals is committed to resolving this issue and ensuring consumer safety. Stay informed and act promptly to safeguard your health.