Archive · 6 Jun 2025
Amneal Pharma Recalls UTI Tablets Due to Contamination
Amneal Pharma is taking back some medicine used for treating urinary tract infections because some pills have tiny germs on them.
This means there might be little black spots on the medicine.
They are recalling three groups of these pills.
The medicine comes in bottles with 100 or 500 pills, but only a certain type is affected.
The company hasn't heard of anyone getting sick from the pills yet.
The FDA has announced the recall.
They want to make sure the medicine is safe for everyone.
Amneal Pharmaceuticals is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg in the U.S.
The recall is due to microbial contamination, causing black spots on the tablet surface.
The recall is at the consumer level, affecting 100 and 500 tablet count bottles.
Only the 400 mg/80 mg strength is affected.
Amneal Pharmaceuticals has received no reports of adverse events.
- Who
- Amneal Pharmaceuticals
- What
- Recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg.
- When
- Not specified in articles, announced June 5, 2025.
- Where
- U.S.
- Why
- Due to microbial contamination causing black spots on the tablet surface.
- Drug
- Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg
- Lots Recalled
- Three
- Reason for Recall
- Microbial Contamination
- Recall Level
- Consumer Level
- Affected Packaging
- 100 and 500 tablet count bottles
- Reported Adverse Events
- None