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- 13,567 bottles of 25 mg chlorthalidone tablets were recalled after failing lab tests, according to the FDA.
- It’s the manufacturer’s second recall of the tablets this year, all with the same expiration date.
- Together, the two Class II recalls cover 25,027 bottles, according to FDA enforcement reports.
Some people taking a common blood pressure medication may have pills that don’t dissolve the way they should.
More than 13,500 bottles of 25 mg chlorthalidone tablets are under a nationwide recall after failing lab tests, according to the Food and Drug Administration (FDA).
Inventia Healthcare Limited voluntarily recalled the tablets on September 3, 2026, according to the FDA’s enforcement report.
The report lists the reason for the recall as “Failed Dissolution Specifications.” That means the tablets failed a test that measures how the medicine is released from the pill, according to the FDA.
“Chlorthalidone is a diuretic, or ‘water pill,’ commonly used to treat high blood pressure and reduce excess fluid retention in the body,” Cheng-Han Chen, MD, a board certified interventional cardiologist at MemorialCare Saddleback Medical Center in Laguna Hills, CA, told Healthline.
This is the second time this year Inventia has recalled its 25 mg chlorthalidone tablets.
The first recall was initiated on June 5 and covered 11,460 bottles. Both were for the same reason: failed dissolution specifications, according to FDA enforcement reports.
Together, the June and September recalls cover 25,027 bottles.
Which chlorthalidone tablets are being recalled?
The FDA classified both recalls as Class II.
The two recalls cover three batches of the chlorthalidone tablets, USP, 25 mg, according to the FDA enforcement reports. All three expire in April 2027.
The 25 mg tablets are light yellow, round and flat, with “103” stamped on one side and nothing on the other, according to the drug label.
September 2026 recall (recall number D-0852-2026)
Recall initiated on September 3, 2026; 13,567 bottles affected.
- Batch: RISA24002
- 100-tablet bottles
- NDC 64980-599-01
June 2026 recall (recall number D-0610-2026)
Recall initiated on June 5, 2026; 11,460 bottles affected.
- Batch RISA24001
- 100-tablet bottles
- NDC 64980-599-01
- Batch RISB24002:
- 1,000-tablet bottles
- NDC 64980-599-10
How to check if your blood pressure medication is recalled
Patients whose supply is part of the recall “should contact their pharmacy to discuss obtaining a replacement and ask whether they should continue taking the medication in the meantime,” Chen said.
For Class II recalls, people can generally keep taking the medicine unless the recalling company gives other instructions, according to the FDA.
In some cases, stopping a medication may be more harmful than continuing to take the recalled medicine, the agency said.
If you’re concerned that your medication has been recalled, here’s what you can do:
- Call the pharmacy where you last refilled your prescription.
- Ask for the manufacturer, NDC, and batch number on file.
- Compare those against the recall lists above.
Are there health risks associated with a Class II recall?
A Class II recall means using the drug may cause temporary health problems, but the chance of serious harm is unlikely, according to the FDA.
“The voluntary recalls cited are classified as Class II, at the retail level,” an FDA Spokesperson told Healthline.
A retail-level recall means the company is “removing the product from retail stores and pharmacy shelves,” Ileana Elder, a branch chief in the FDA’s Office of Compliance, said in an FDA podcast. When a recall doesn’t extend to consumers, stopping a medication unnecessarily can be more harmful, and patients should contact their pharmacy with questions, Elder said.
Healthline reached out to the companies for more information about the September recall, but had not heard back by the time of publication. The FDA referred further questions to the companies
However, based on a preliminary assessment of the batches recalled in June, Rising Pharma Holdings, a distributor of one of the recalled lots, stated that “no impact on patient health and safety is anticipated.”
“If a medication does not dissolve at the expected rate, it may not be absorbed by the body as intended,” Chen said. “This can reduce the amount of medication that reaches the bloodstream and potentially decrease its effectiveness.”
What do ‘failed dissolution specifications’ mean for medications?
In a dissolution test, a lab places a tablet in a controlled liquid medium to determine whether and how quickly the active ingredient is released, according to FDA guidance on dissolution testing.
A failed result means the batch didn’t meet the release standard set for that product, according to FDA guidance on drug quality standards.
Manufacturers propose and justify these standards, and regulators approve them as part of drug approval, according to the same guidance.
In the United States, the official standards stay the same from the time a drug is released until it expires, the guidance said.
The September FDA enforcement report doesn’t say how the recalled tablets failed. A notice from Rising Pharma Holdings about the June recall provides more details.
Rising found two problems at the 18-month mark of ongoing quality testing of its 25 mg tablets, the company said in a notice posted by the California State Board of Pharmacy:
- The tablets contained less chlorthalidone than the approved minimum: 91.5% of the labeled amount, when the minimum is 92%.
- On average, 78% of the medication dissolved during the test. The standard requires at least 80%.
What is chlorthalidone used for?
According to the drug label, chlorthalidone treats:
- High blood pressure (hypertension) — alone or added to other blood pressure medications, or in more severe cases.
- Swelling linked to heart failure, liver scarring, and corticosteroid or estrogen therapy, as an add-on treatment.
- Swelling from some kidney conditions.
The label recommends that most people with high blood pressure start with one 25 mg dose per day. That’s the strength involved in both 2026 recalls.
