Blood pressure medication recall list

A blood pressure medication recall list tracks which antihypertensive drugs the FDA has recalled, by drug name, manufacturer, lot number, recall class, and reason.

The best-known entries are three angiotensin receptor blockers (ARBs), valsartan, losartan, and irbesartan, recalled in 2018 and 2019 for nitrosamine impurities. Amlodipine/valsartan combination tablets and some metoprolol lots have been recalled too.

According to the FDA, a drug is recalled when it poses a potential health risk from manufacturing defects, contamination, mislabeling, or superpotency. Practices use the list to check whether a patient’s prescription is affected and to advise them safely.

This guide covers each recall, what clinicians need to check, and a downloadable checklist your practice can use to record each patient’s recall response.

Key takeaways

A blood pressure medication recall list tracks FDA recalls by drug name, manufacturer, lot number, recall class, and reason, so your team can check prescriptions.

Nitrosamine impurities (NDMA, NDEA, and NMBA) drove the landmark 2018–2019 ARB recalls of valsartan, losartan, and irbesartan.

FDA recall classes run from Class I (serious health risk) to Class III (unlikely to cause harm). The class sets how fast you contact patients.

Verify lot numbers against FDA recall notices, contact affected patients, and document each step so your recall response holds up in an audit.

Pabau, the practice management platform we build, keeps prescriptions, patient messages, and recall notes in one record, so the response is documented as it happens.

How to use the recall checklist

Use this page as the reference and the downloadable checklist as the record. The page lists each recall, its reason, and its FDA class. The checklist captures one patient’s details and each step your team confirms.

Start by matching the patient’s prescription lot number to the recall notice. Then record how and when you contacted them. Finish with the alternative prescribed and who signed off, so the file holds up in an audit.

Recalled blood pressure medications at a glance

The table below summarizes the main recalls affecting blood pressure medications. Recall classes and dates follow FDA recall notices, and each notice lists the affected lot numbers.

Check the FDA recall notice for each drug’s affected lot numbers before you contact a patient. New recalls are issued regularly, so search the FDA’s recall page for anything announced after this list was compiled.

Losartan recalls: What clinicians need to know

Losartan potassium recalls began in 2018, when manufacturers detected N-nitrosodiethylamine (NDEA) and N-nitroso-N-methyl-4-aminobutyric acid (NMBA) in the drug. Both are probable human carcinogens. Losartan is prescribed to millions of patients worldwide, which made this one of the most consequential medication recalls in recent years.

The impurities came from the synthesis process at certain suppliers, and not every losartan manufacturer was affected. The FDA requested a recall of affected lots. Affected patients were advised to switch to an unaffected ARB or another drug class under physician guidance. Verify the lot number on each dispensed bottle against FDA lists before assuming a supply is safe.

Valsartan recalls and NDMA contamination

The 2018 valsartan recall was the first major nitrosamine contamination event in ARB medications. Valsartan active pharmaceutical ingredient (API) from Zhejiang Huahai Pharmaceutical contained NDMA above the FDA’s acceptable daily intake limit.

The recall triggered inspections of other manufacturers, which found similar impurities in losartan and irbesartan. The valsartan recall is largely resolved. Still, check older prescriptions against the lot lists to confirm no patient kept taking an affected supply.

FDA recall classes: What each risk level means

The FDA sorts recalls into three classes, based on how likely harm is and how serious it would be:

• Class I recall: A serious health hazard or death is possible. Example: a drug with dangerous chemical contamination. Contact the patient and the prescriber immediately.
• Class II recall: The product may cause temporary or medically reversible health problems, and the chance of serious harm is remote. Most medication recalls fall here, including the nitrosamine recalls. Notify patients and counsel them on next steps without causing alarm.
• Class III recall: The product is unlikely to cause harm. Example: a labeling error that doesn’t affect drug safety. Notification is often handled at the pharmacy level.

Blood pressure medication recalls are usually Class II. That calls for an orderly dose review and a planned switch, not an emergency stop. Getting the class right tells your team how fast to act.

What causes blood pressure drug recalls?

Blood pressure drug recalls come from four main causes: nitrosamine contamination, superpotency, mislabeling, and manufacturing defects.

Nitrosamine contamination: This is the most common cause of recent blood pressure recalls. Nitrosamines (NDMA, NDEA, NMBA) are probable carcinogens that can form during chemical synthesis if impurities aren’t removed. ARBs proved especially susceptible because of their chemical structure and manufacturing routes. The chart below shows which impurity turned up in which drug.

Superpotency: A batch contains more active ingredient than the label states. In blood pressure medication, that raises the risk of low blood pressure (hypotension) and fainting (syncope) in susceptible patients.

Mislabeling or packaging errors: Bottles carry the wrong drug name, strength, or directions. These can lead to wrong-drug errors or overdose.

Manufacturing defects: Visible particles, discoloration, or instability point to a quality control failure during production or storage.

How to check whether a patient’s medication is recalled

Five checks tell you whether a patient’s current prescription is affected:

1. Collect the bottle information: Ask the patient for their medication bottle, or open their prescription record. You need the drug name, strength, manufacturer, lot number, and expiration date.
2. Visit the FDA recalls page: Go to FDA.gov/safety/recalls-market-withdrawals-safety-alerts and search for the drug name.
3. Match the lot number: Compare the patient’s lot number against the recall notice, which lists the affected lots and the recall date.
4. Check the recall class: Class I, II, or III sets the urgency. A Class II recall usually allows a few days for outreach, while Class I needs same-day contact.
5. Log the result: Record the patient, lot number, contact attempt, and outcome on the downloadable checklist for your audit trail.

Clinical action steps when a recalled lot is identified

When a patient’s prescription matches a recalled lot, follow these six steps to protect the patient and document compliance:

1. Notify the patient promptly. Call, text through secure clinical messaging, or email through a HIPAA-compliant platform. Use plain language: “We’ve found a safety concern with your blood pressure medication lot. We’re arranging an alternative for you. Please don’t stop taking your medication before we’ve spoken.”
2. Alert the prescriber if you aren’t the prescriber. The patient’s physician or nurse practitioner can then issue a new prescription for an alternative ARB or a different drug class.
3. Move the patient to an alternative. Don’t leave the patient without blood pressure coverage. Options include another manufacturer’s losartan, valsartan or irbesartan from an unaffected supplier, or a different class such as a beta-blocker or calcium channel blocker.
4. Document the recall response in the patient’s record. Note the notification date, contact method, patient acknowledgment, alternative prescribed, and the date the new prescription was filled. Pabau’s clinical record system lets you flag the recall entry so the whole team sees it.
5. Report adverse events if applicable. If the patient had symptoms or side effects from the recalled lot, file a report through the FDA’s MedWatch program, online or by mail. These reports help the FDA track how a recall affected patients.
6. Keep audit records. List every affected patient, notification date, and outcome. Regulators, such as state boards in the US or the CQC in England, may ask for these records during an inspection.

Two companion templates help after the switch. A repeat prescription request form records the new prescription. A blood pressure reading chart tracks readings while the patient settles on the alternative.

How Pabau handles drug recall notifications

Without a connected system, a recall usually runs from a spreadsheet. Someone searches prescriptions by hand, phones patients one at a time, and types notes into separate files.

Pabau keeps the recall response inside the patient record. Its prescription management holds each patient’s medication history in the same file as their notes, so affected patients are easier to find. When a recall lands, your team can:

• Add an alert to each affected patient’s record, so every clinician sees it at the next contact.
• Send an SMS or email to the affected patients as one group, instead of calling each one.
• Log each contact and note with a timestamp against the patient record.

If a patient reports a visible reaction, such as a rash or swelling, Pabau’s clinical photo tools store dated images in the same record. That evidence supports a MedWatch report. Book a demo to see how Pabau’s clinical records and patient messaging speed up your recall response.

Run recall responses from the patient record

Pabau keeps prescriptions, alerts, patient messages, and notes in one record. Your team can find affected patients, contact them, and document each step in one place.

Book a demo

Conclusion

Work from the lot number. Two patients on the same losartan strength can hold different lots, and only one of them may be affected.

Bookmark the FDA recall page, print the checklist before you need it, and decide now who on your team owns recall outreach. Then a Class II notice becomes a few days of orderly calls instead of a scramble.

Book a demo to see how Pabau keeps each recall contact documented in the patient record.

Continue your research

Need to check a patient’s other medications? Blood thinning medication list covers the anticoagulants and antiplatelets that often sit alongside blood pressure prescriptions.

Want to monitor readings after a switch? Blood pressure reading chart gives patients a simple way to log readings while they settle on an alternative.

Looking for a medication management workflow? Prescription management tracks medication history and supports flagging and recall cross-referencing.

Tracking doses during a medication change? Daily medication chart records each dose, so missed or doubled doses show up quickly.

Assessing a patient’s wider cardiovascular risk? Blood pressure stroke risk chart maps readings to stroke risk for patient conversations.

Frequently asked questions