The recall you’re referring to involves about 590,000 bottles of prazosin hydrochloride, a prescription medication primarily used to treat high blood pressure (and sometimes prescribed for PTSD-related nightmares).
Why was it recalled?
The manufacturer, Teva Pharmaceuticals USA, voluntarily recalled multiple lots after testing found N-nitroso prazosin impurity C, a type of nitrosamine, at levels above the FDA’s acceptable limit. Nitrosamines are chemicals that can increase the risk of cancer if people are exposed to them at high levels over long periods.
How serious is the recall?
The FDA classified it as a Class II recall, which means:
- Use of the product may cause temporary or medically reversible adverse health consequences, or
- The probability of serious adverse health consequences is considered remote.
Which products were affected?
The recall covers certain lots of:
- Prazosin hydrochloride 1 mg capsules
- Prazosin hydrochloride 2 mg capsules
- Prazosin hydrochloride 5 mg capsules
Only specific lot numbers were recalled—not every bottle of prazosin.
What should patients do?
If you’re taking prazosin:
- Do not stop taking it suddenly without speaking with your healthcare provider, as uncontrolled blood pressure can be dangerous.
- Check your bottle’s lot number against the FDA recall notice or contact your pharmacist.
- If your medication is from an affected lot, your pharmacist or prescriber can help arrange a replacement.
If you have a bottle of prazosin, I can also help you determine whether your specific lot number is included in the recall.