The latest U.S. recall covers a specific batch of chlorthalidone 25 mg tablets—not every prescription for the blood-pressure medicine. Inventia Healthcare Limited initiated the recall on September 3, 2026, after the tablets failed dissolution specifications. The U.S. Food and Drug Administration classified it as a Class II recall on September 17.
The affected product was distributed nationwide in the United States by Rising Pharma Holdings. The recall covers 13,567 bottles containing 100 tablets each. Patients and caregivers should compare the label on their bottle with the identifiers below, then call the dispensing pharmacy for instructions.
Which chlorthalidone bottles are included?
| Medicine |
Chlorthalidone Tablets, USP, 25 mg |
| Bottle size |
100 tablets |
| NDC |
64980-599-01 |
| Batch |
RISA24002 |
| Expiry |
April 2027 |
| Recall number |
D-0852-2026 |
If the batch, strength, bottle size or NDC does not match, the latest recall notice does not by itself establish that your medicine is affected. A pharmacist can verify the manufacturer and lot information when the pharmacy label obscures the original container.
What does “failed dissolution” mean?
Dissolution testing measures how a tablet releases its active ingredient under standardized conditions. A failure does not mean the medicine contains a poison or foreign contaminant. It raises a different concern: the tablet may not release the medicine as expected, which could affect how much becomes available for absorption and how reliably it controls blood pressure.
A recall notice is a reason to verify the bottle promptly—not a reason to stop a prescribed blood-pressure medicine without professional advice.
The FDA’s Class II category means use of the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious harm is remote. Independent reports reviewing the FDA record said no illnesses had been linked to this recall at the time of publication.
What should patients do now?
- Do not stop on your own. Suddenly interrupting prescribed blood-pressure treatment can create its own risk. Keep taking the medicine unless a pharmacist or clinician gives different instructions.
- Check the label. Compare the strength, NDC, batch number and expiration date with the table above.
- Call the dispensing pharmacy. Ask whether your bottle came from the recalled batch and how it should be returned or replaced.
- Monitor as directed. If you already check blood pressure at home, continue following the schedule set by your clinician and report unusual readings or symptoms.
- Seek urgent care for an emergency. Chest pain, severe breathing difficulty, fainting or signs of stroke require immediate medical attention rather than waiting for a recall callback.
Our related medicine-safety guide explains what to do when a tablet seems stuck and why patients should not repeat a dose when they are uncertain whether it was swallowed.
Is this the same as the earlier June recall?
No. It is a separate recall involving another batch from the same manufacturer. In June 2026, 11,460 bottles were recalled after the same type of dissolution failure. The latest September action covers 13,567 additional bottles. Adding the two totals describes two recalls, but patients should use the exact batch information—not a combined headline number—to decide whether their bottle may be involved.
Does the recall apply outside the United States?
The FDA record describes U.S. nationwide distribution through a New Jersey distributor. It does not establish that all chlorthalidone made elsewhere, or all supplies in other countries, are recalled. Readers in Canada, the United Kingdom, Australia, Iran and other markets should check their national medicines regulator or local pharmacist if they have concerns about a product with matching identifiers.
This distinction matters because chlorthalidone is a generic medicine made and sold by multiple companies. The drug itself remains an established prescription diuretic used to treat high blood pressure and fluid retention; the current action concerns product quality in identified batches.
Frequently asked questions
Was all chlorthalidone recalled?
No. The latest notice identifies one 25 mg batch in 100-count bottles. Other strengths, manufacturers or batches are not automatically included.
Should I throw the tablets away?
Contact the pharmacy first. It can confirm the lot and provide the correct return or replacement procedure while helping prevent a treatment gap.
Is a Class II recall the FDA’s highest level?
No. Class I is the most serious category. Class II means serious consequences are considered remote, although temporary or medically reversible harm may be possible.
AsiaNewsIran will update this report if the FDA record, affected batches or patient instructions change. If your bottle matches the identifiers, contact your pharmacist and share the verified guidance with anyone who may use the same medicine.