FDA says presence of cancer-linked chemical in blood pressure medicine led to recall

The FDA, in coordination with manufacturers and distributors, has issued a recall notice covering certain lots of prazosin hydrochloride capsules — including the 5 mg strength in 20-capsule cartons (NDC 60687-572-32) distributed by American Health Packaging. 

The reason: lab tests found levels of a nitrosamine impurity that exceed the FDA’s acceptable intake thresholds. Nitrosamines are a class of compounds that may increase cancer risk if people are exposed to them over time, even at low levels.

The recall classification is labeled as Class II, which means that while serious health consequences are unlikely, the product may cause temporary or medically reversible adverse health outcomes if used. 

Why this matters to you

If you or someone you care for takes prazosin (for hypertension, post-traumatic stress disorder–related sleep disturbances, or other off-label uses), this recall could affect the pills you have. Even though the risk is described as remote for serious effects, the impurity exceeds safety limits and so the drug no longer meets the FDA’s quality standards for those lots.

Because prazosin works by relaxing blood vessels and lowering blood pressure, abrupt discontinuation without substituting another therapy may raise the risk of unmanaged hypertension or other complications. So the key message: don’t stop it on your own — consult your prescriber or pharmacist to safely transition away from the affected lots.

What to do

1. Check your medication: Look at your prazosin prescription cartons or blister packs. If you have the 5 mg strength in a 20-capsule carton with NDC 60687-572-32 (distributed by American Health Packaging) — and/or if your lot number or expiration date matches those listed in the recall notice — it may be part of the recall. (Note: lots of other strengths and NDCs are also affected under the broader recall by the manufacturer.
2. Contact your pharmacist or healthcare provider: They can help determine whether your specific lot is included, arrange for a replacement medication or alternative therapy, and help monitor your blood pressure if a change is made.
3. Do not stop taking the drug outright without professional guidance: Because the medication is for a serious condition (such as high blood pressure), stopping it may create more immediate health risks than the potential long-term exposure.
4. Dispose of the recalled product safely if you are instructed to do so, or return it to the pharmacy per the recall instructions.
5. Keep monitoring your blood pressure and any symptoms of dizziness, light-headedness or other side effects; report any unusual changes to your provider.

What to ask your healthcare provider or pharmacist

• “Is the lot number of my prazosin affected by this recall?”
• “What alternative medication can I switch to, and what are the risks/benefits of that switch?”
• “When switching, how should I monitor my blood pressure, and are there special instructions for the transition?”
• “If I have additional bottles at home, should they be returned or disposed of, and how?”

While the immediate risk from this recall of prazosin appears low, the presence of a potentially cancer-causing impurity means the medication no longer meets safety standards. If you are taking any form of prazosin, especially the 5 mg 20-capsule cartons under NDC 60687-572-32, act promptly: examine your medicine, consult your healthcare provider, and safely transition if needed — without stopping treatment abruptly.