Archive · 31 Oct 2025
Teva Pharmaceuticals Recalls Prazosin Hydrochloride Due to Cancer Impurity
A company called Teva Pharmaceuticals is taking back over 580,000 bottles of a medicine called Prazosin Hydrochloride.
This medicine is used to treat high blood pressure and sometimes sleep problems.
The reason for the recall is that the medicine might have a small amount of a chemical called N-nitroso Prazosin impurity C. This chemical could possibly cause cancer if someone takes the medicine for a very long time.
The FDA, which checks medicine safety, called this a Class II recall.
This means that if someone takes the medicine, it's not likely to cause very serious health problems, and any issues might only be temporary.
The companies decided to recall the medicine to be safe.
People who have this medicine should check if their bottles are part of the recall and talk to their doctor before they stop taking it, because stopping blood pressure medicine suddenly can be dangerous.
Teva Pharmaceuticals USA and Amerisource Health Services have voluntarily recalled over 580,000 bottles of Prazosin Hydrochloride capsules nationwide.
The recall is due to the presence of N-nitroso Prazosin impurity C, a potentially cancer-causing chemical, found at levels exceeding acceptable intake limits.
Prazosin Hydrochloride capsules are used to treat high blood pressure and other sleep disturbances, and are available in 1 mg, 2 mg, and 5 mg doses.
The FDA classified this recall as Class II, indicating a lower risk of serious health consequences, with potential for temporary or reversible adverse effects.
Patients are advised to contact their pharmacy to determine what to do with remaining medication and to consult healthcare providers before discontinuing the drug.
- Who
- Teva Pharmaceuticals USA and Amerisource Health Services
- What
- Voluntary recall of over 580,000 bottles of Prazosin Hydrochloride capsules
- When
- Recall initiated October 7
- Where
- Nationwide U.S.
- Why
- Detection of N-nitroso Prazosin impurity C, a potentially cancer-causing chemical, at levels exceeding acceptable intake limits
Recall Classification
Potential Risk
Severity of Health Risk
Recall Classification
The FDA classified the recall as Class II.
Potential Risk
Class II classification means that the drug could cause "temporary or medically reversible health issues," though serious harm is unlikely.
- Drug Name
- Prazosin Hydrochloride capsules
- Distributor
- Teva Pharmaceuticals USA and Amerisource Health Services
- Reason for Recall
- Presence of N-nitroso Prazosin impurity C, a potentially cancer-causing chemical, above acceptable intake limits
- Recall Classification
- Class II
- Total Bottles Recalled
- 580,844
- Strengths Recalled
- 1 mg, 2 mg, 5 mg
- Recall Initiation Date
- October 7
