Chlorthalidone tablets are under a nationwide U.S. recall after the FDA classified 13,567 bottles as a Class II drug recall because the product failed dissolution specifications.
The affected medicine is a 25 mg prescription tablet used to help control high blood pressure and manage certain types of fluid retention.
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Which chlorthalidone product is affected
The recall applies to 100-count bottles of Chlorthalidone Tablets USP, 25 mg, manufactured by Inventia Healthcare Limited and distributed by Rising Pharma Holdings Inc.
The affected bottles carry National Drug Code 64980-599-01, lot RISA24002 and an expiration date of April 2027.
The product was distributed throughout the United States, meaning patients in multiple states may have received the affected lot through pharmacies or other prescription channels.
Why the FDA issued the recall
The tablets failed dissolution specifications during quality testing.
Dissolution testing examines how a tablet releases its active ingredient so it can be absorbed by the body.
If a tablet does not dissolve as expected, the amount and timing of medication available for absorption may be affected, potentially reducing the intended treatment effect.
The recall was initiated by the company on September 3, 2026, and the FDA classified it as Class II on September 17, 2026.
The FDA uses a Class II classification when a product may cause temporary or medically reversible health effects, or when the likelihood of serious harm is considered remote.
What patients taking chlorthalidone should do
Patients should check the label on their bottle for the product name, strength, NDC number, lot number and expiration date.
- Product: Chlorthalidone Tablets USP
- Strength: 25 mg
- Bottle size: 100 tablets
- NDC: 64980-599-01
- Lot: RISA24002
- Expiry: April 2027
Anyone who believes they have the recalled lot should contact a pharmacist or prescribing health professional for instructions before making a change to treatment.
Patients should not stop a blood pressure medication on their own without medical advice, particularly if it has been prescribed as part of a broader plan to control hypertension or fluid levels.
A pharmacist can verify whether the bottle is part of the recall and explain whether a replacement prescription or another supply is needed.
People who experience concerning symptoms after taking any medication should seek medical advice promptly, and emergency care should be considered for severe or rapidly worsening symptoms.
What chlorthalidone is used for
Chlorthalidone is a long-acting diuretic, sometimes described as a water pill, that helps the body remove excess sodium and water.
It may be prescribed for high blood pressure and for swelling associated with conditions such as heart failure, liver disease or other medical problems.
Because the medication can affect blood pressure, fluid balance and electrolytes, patients should discuss any replacement or interruption with a healthcare professional.
This is the second chlorthalidone recall in 2026
The September action follows a separate June 2026 recall involving other chlorthalidone lots distributed by Rising Pharma.
That earlier recall involved 25 mg tablets in 100-count and 1,000-count bottles after testing found results below approved assay and dissolution specifications.
The June recall listed lots RISA24001 and RISB24002, which are different from the September lot RISA24002.
Patients should compare the complete lot number rather than relying only on the medicine name or strength, since recalls generally apply to specific lots and package sizes.
What happens next
The recall remains an ongoing voluntary action involving the identified lot.
Pharmacies and distributors are expected to identify affected inventory and remove it from availability in accordance with the recall process.
The FDA’s drug recall records provide the formal product and lot information, while patients should use their pharmacist or prescriber as the main source of advice about replacement treatment.
Canadian patients should not assume that a U.S. recall automatically applies to every chlorthalidone product sold in Canada, because packaging, manufacturers and lot numbers can differ by market.
However, anyone in Canada who has a bottle matching the U.S. product details should contact the dispensing pharmacy or a healthcare professional to confirm whether action is required.
Frequently Asked Questions
What chlorthalidone product has been recalled?
The recall affects 25 mg Chlorthalidone Tablets USP in 100-count bottles with NDC 64980-599-01, lot RISA24002 and an April 2027 expiry date.
Why was chlorthalidone recalled?
The affected tablets failed dissolution specifications, meaning they may not release the active ingredient as expected.
What does an FDA Class II recall mean?
It means the product may cause temporary or medically reversible health effects, or that serious harm is considered unlikely.
Should I stop taking recalled chlorthalidone?
Do not stop or change treatment without speaking with a pharmacist or prescribing health professional, who can confirm the lot and arrange replacement advice.
Does this U.S. recall affect chlorthalidone sold in Canada?
Not necessarily, because Canadian products may have different manufacturers, packaging and lot numbers, but patients should ask their pharmacy to verify any matching product.
Fact-Checked: Key product, lot, classification and recall details were checked against FDA drug recall and enforcement information, with supporting pharmacy recall records reviewed.
Disclaimer: This article is for general information and does not replace advice from a pharmacist, prescriber or other qualified healthcare professional.