RecallRadar
ModerateReported June 24, 2026 (8 weeks ago)

Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle

Recalled by Inventia Healthcare Limited

Product image for Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA.  Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816.  NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10
Product image via news and web sources. It may show general packaging and not the exact recalled lot — always confirm using the codes below.

Class II — moderate

Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Inventia Healthcare Limited has recalled Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on June 24, 2026 and was initiated on June 5, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, with approximately 11,460 bottles affected. The company behind the recall is Inventia Healthcare Limited, based in Kalyan. The FDA describes the product as: “Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 088…”

Why was Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle recalled?

According to the FDA, the stated reason for the recall is: “Failed Dissolution Specifications.” In plain terms, this recall relates to a potency or effectiveness issue.

This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.

What should you do?

If you think you may have bought Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, compare it against the product description and identifying codes ([100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Inventia Healthcare Limited or your local health authority.

About this recall

This recall was distributed in U.S. Nationwide.. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.

Who this recall affects

This recall matters to anyone who bought Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.

Distribution listed in the notice: U.S. Nationwide..

What potency or effectiveness issue actually means

This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.

In this case, the concern applies specifically to Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle from Inventia Healthcare Limited — not to the wider category of products. Similar items from other brands aren't part of this recall.

How to check whether you have it

On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.

Compare what you find against the identifying details in this recall: [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027

What to do if you already bought it

Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.

Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.

If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.

Full recall details

Status
Ongoing
Date reported
June 24, 2026
Recall started
June 5, 2026
Distributed in
U.S. Nationwide.
What was recalled
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10
Why it was recalled (as stated by the FDA)
Failed Dissolution Specifications
How to identify the affected product
[100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
Amount recalled
11,460 bottles

What you can do

Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.

Quick answers

Why was Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle recalled?+

According to the FDA: Failed Dissolution Specifications

How serious is this recall?+

Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

What should I do if I have Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle?+

Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.

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View the official FDA record

Opens the U.S. Food and Drug Administration (FDA) data for this recall.

Recall number: D-0610-2026. Information last synced from the FDA on August 20, 2026.