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Blood Pressure Drug Recalled Because Tablets May Not Dissolve Properly
More than 25,000 bottles of chlorthalidone affected nationwide
2-minute read
Key takeaways
- More than 25,000 bottles of chlorthalidone tablets (25 mg) were recalled nationwide after failing dissolution quality standards.
- The FDA classified the recall as Class II, indicating temporary or medically reversible health consequences are possible.
- Patients should check recalled lot numbers and consult a health care provider before stopping treatment.
More than 25,000 bottles of the prescription blood pressure medication chlorthalidone have been recalled nationwide because the tablets failed quality standards for how they dissolve after being taken.
The Food and Drug Administration (FDA) classified the recall as Class II, meaning use of the product may cause temporary or medically reversible adverse health consequences, or that the risk of serious adverse health consequences is remote.
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What medication was recalled?
The recalled medication is chlorthalidone tablets (25 mg), a prescription diuretic commonly used to treat high blood pressure and fluid retention. The recall affects chlorthalidone tablets manufactured by Inventia Healthcare Limited in Ambernath, India, and distributed nationwide by Rising Pharma Holdings, Inc.
The recalled tablets failed to meet dissolution specifications, according to the FDA. In plain terms, this means the tablets may not dissolve properly after being taken. Dissolution testing helps ensure that a medication breaks down and releases its active ingredient as intended, allowing the body to absorb it properly.
The recalls were initiated voluntarily by the manufacturer.
Which products are affected?
The recalls involve the following products distributed nationwide in the United States:
Chlorthalidone tablets, USP, 25 mg
100-tablet bottles
- NDC: 64980-599-01
- Lot number: RISA24001
- Expiration date: April 2027
1,000-tablet bottles
- NDC: 64980-599-10
- Lot number: RISB24002
- Expiration date: April 2027
Approximately 11,460 bottles are included in this part of the recall.
Additional chlorthalidone tablets, 25 mg
100-tablet bottles
- NDC: 64980-599-01
- Lot number: RISA24002
- Expiration date: April 2027
Approximately 13,567 bottles are included in this part of the recall.
Together, the two recalls affect more than 25,000 bottles of the medication.
What should consumers do?
Patients should check their prescription bottles to see whether the lot number matches that of a recalled product.
Do not stop taking a prescribed blood pressure medication without first speaking with your health care provider. Suddenly stopping treatment can pose health risks for some patients.
If your medication was repackaged by the pharmacy in an orange prescription bottle, the lot number may not be listed on the label. If you cannot find it, contact your pharmacy. A pharmacist should be able to determine which lot number was used to fill your prescription.
For recalled medication, contact your pharmacist or prescribing physician for guidance on obtaining a replacement or alternative.
How to report problems
Consumers and health care professionals can report adverse events or quality problems involving medications through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
For more information or to submit a report, visit the FDA’s MedWatch website or call 800-FDA-1088.
This article used AI tools to compile recall data. An AARP editor reviewed and refined the content for accuracy and clarity.
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