Tag: Chlorthalidone Recall

  • Blood Pressure Medication Recall: Which Chlorthalidone Lots Are Affected and What Patients Should Do

    Blood Pressure Medication Recall: Which Chlorthalidone Lots Are Affected and What Patients Should Do

    A 2026 recall checker for lot numbers, NDCs, dissolution failures, replacement steps, and Class II risk

    A nationwide blood pressure medication recall in 2026 affected specific lots of chlorthalidone 25 mg after the tablets failed dissolution quality testing. It does not apply to every chlorthalidone prescription or every blood-pressure medicine. Patients should compare the NDC, batch number, bottle size, and expiration date.

    Across the June and September 2026 actions described by Healthline, 25,027 bottles were affected. Both were Class II recalls. FDA says people can generally continue Class II medicines unless different instructions are given, because abruptly stopping treatment may create more risk while a replacement is arranged.

    Which Chlorthalidone Products Were Recalled?

    Recall Bottle size NDC Batch / lot Expiration Quantity
    September 2026 100 tablets 64980-599-01 RISA24002 04/2027 13,567 bottles
    June 2026 100 tablets 64980-599-01 RISA24001 04/2027 Part of 11,460 bottles
    June 2026 1,000 tablets 64980-599-10 RISB24002 04/2027 Part of 11,460 bottles

    Important: The matching details matter. A bottle containing chlorthalidone 25 mg is not automatically recalled simply because the drug name and strength match. The NDC and batch information must also match the affected product.

    What is chlorthalidone and why does the recall matter?

    Chlorthalidone is a prescription diuretic used for high blood pressure and some forms of fluid retention. DailyMed lists the recalled source product as a light-yellow, round 25 mg tablet with imprint 103 and source NDC 64980-599.

    Blood-pressure treatment depends on reliable dosing. If a tablet does not release the active ingredient as expected, drug performance may be less reliable.

    What does “failed dissolution specifications” mean?

    Dissolution testing measures how a tablet releases its active ingredient. A failed result does not mean every tablet contains no medicine. It means the tested batch did not meet the approved release standard.

    For the June lots, Healthline reported a mean dissolution result of 78% when at least 80% was required, plus an assay result of 91.5% when the approved minimum was 92%. The September report cited failed dissolution specifications without publishing the same detailed values.

    What does a Class II recall mean for patients?

    Question What Class II means What it does not mean
    Is this the highest-risk FDA recall? No. Class II means temporary or medically reversible health effects are possible, or serious harm is considered remote. It is not a Class I recall, the category used when serious harm or death is reasonably probable.
    Should everyone stop the drug immediately? Not usually. FDA says Class II patients can generally continue unless different instructions are given. A recall is not automatic permission to stop a prescribed hypertension medicine without guidance.
    Does Class II mean the product is fine? No. The product failed an approved quality requirement and is being removed or corrected. The lower recall class does not mean the quality failure should be ignored.
    Is every chlorthalidone product affected? No. Recalls apply to identified products, lots, and package codes. The drug name alone is not enough to determine whether your prescription is recalled.

    How can you check whether your bottle is affected?

    Check the drug name, 25 mg strength, NDC, batch number, and expiration date. All recalled batches expire in April 2027.

    If your pharmacy used an amber prescription bottle, the manufacturer lot may not appear. Call the dispensing pharmacy and ask whether your prescription came from batch RISA24001, RISB24002, RISA24002, or another lot.

    What should you do if your medication matches the recall?

    Situation Best next step Why
    Your NDC and batch match Contact your pharmacist promptly and ask about a replacement. Contact the prescriber if the pharmacy directs you to do so. The supply may be part of the recalled lot.
    The bottle has no lot number Call the pharmacy with your prescription details. Pharmacy dispensing records may identify the manufacturer and source lot.
    You take chlorthalidone but the details do not match Do not assume your medicine is recalled. Continue checking official information if concerned. Only identified lots are included in this recall.
    You already took tablets from a recalled lot Do not panic or double future doses. Ask your pharmacist or clinician what to do next. A Class II recall does not mean serious injury is expected from every dose.
    Your blood pressure is unusually high or you feel unwell Contact a healthcare professional. Seek urgent care for severe symptoms. Medication performance is only one possible cause and needs medical evaluation.

    Why should you not stop blood-pressure medicine suddenly?

    Poorly controlled hypertension increases the risk of stroke, heart attack, heart failure, kidney disease, and other complications. That is why recall guidance emphasizes arranging a replacement instead of simply stopping treatment.

    Do not take extra chlorthalidone, switch diuretics on your own, or use someone else’s prescription. A pharmacist or prescriber can help maintain treatment continuity.

    Does a dissolution failure cause new side effects?

    The recall was triggered by a product-quality test, not a new side-effect syndrome. Known chlorthalidone effects can include dizziness, electrolyte changes, dehydration, and increased urination.

    If you have new symptoms, report them to your clinician rather than assuming they came from the recall. FDA also accepts adverse-event and product-quality reports through MedWatch.

    How do you report a problem with a recalled medication?

    Consumers and healthcare professionals can submit adverse-event or product-quality reports through FDA MedWatch.

    Keep the bottle or packaging until your pharmacist gives return or disposal instructions. The NDC, lot, expiration date, and fill date can help document the problem.

    Frequently Asked Questions About the Blood Pressure Medication Recall

    Which blood pressure medication was recalled in the Healthline report?

    Specific chlorthalidone tablets, USP, 25 mg manufactured by Inventia Healthcare Limited were recalled. The June and September 2026 actions covered batches RISA24001, RISB24002, and RISA24002.

    Were all chlorthalidone tablets recalled?

    No. The recall applies only to specific NDCs, package sizes, lots, and expiration information. Other chlorthalidone products are not automatically included.

    How many bottles were affected?

    Healthline reported 11,460 bottles in the June recall and 13,567 bottles in the September recall, for 25,027 bottles across the two actions.

    What should I do if my orange pharmacy bottle has no lot number?

    Call the pharmacy that filled the prescription. The pharmacy may be able to identify the manufacturer, NDC, and source lot from its dispensing records.

    Should I stop taking recalled chlorthalidone immediately?

    Do not stop a prescribed blood-pressure medicine on your own unless the recalling company, FDA, pharmacist, or prescriber tells you to. FDA notes that Class II patients can generally continue treatment while getting guidance.

    Does failed dissolution mean the pill has no active ingredient?

    No. It means the batch did not meet the approved release specification in testing. The issue is reliable product performance, not proof that every pill contains zero medication.

    What does Class II mean?

    FDA defines Class II as a recall where temporary or medically reversible adverse health consequences may occur, or where the chance of serious adverse consequences is remote.

    How can I keep up with future medication recalls?

    Use FDA drug-recall and enforcement-report resources, keep pharmacy contact information current, and ask your pharmacist about any recall alert that appears to match your prescription.

    Bottom Line

    The 2026 blood pressure medication recall covered specific chlorthalidone 25 mg lots, not all hypertension medicines. Three batches with an April 2027 expiration date were identified across June and September recalls. The reason was failure to meet dissolution quality specifications, and FDA classified both actions as Class II.

    Verify the NDC and batch, contact the dispensing pharmacy if your supply may match, and arrange a replacement without abruptly stopping treatment. If your bottle lacks the batch number, the pharmacy can usually confirm the source lot.