A widely prescribed water pill was recalled because the tablets may not dissolve

Chlorthalidone 25 mg tablets, a long-established diuretic taken for high blood pressure and fluid retention, have been recalled because they failed dissolution testing. A tablet that does not break down on schedule in the digestive tract may release less of its active ingredient than the label promises, which is the specific problem the recall describes.

The product is sold by Rising Pharma Holdings, Inc. and made by Inventia Healthcare Limited of Ambernath, India. FDA has placed the recall in Class II, the middle tier of its three hazard categories, and AARP counts more than 25,000 bottles across three lots.

Three lots and the dissolution failure

According to AARP’s report on the recall, the affected product is chlorthalidone tablets USP, 25 mg, in two bottle sizes. Lots RISA24001 and RISA24002 came in 100-tablet bottles under NDC 64980-599-01, roughly 11,460 and 13,567 bottles respectively, and Lot RISB24002 came in 1,000-tablet bottles under NDC 64980-599-10. All three carry an April 2027 expiration date. Rising Pharma is based in New Jersey, according to the ABC-affiliated report, and Inventia is the Indian manufacturer named on the recall.

The stated reason is that the tablets “may not dissolve properly after being taken,” which affects how the active ingredient is absorbed. A trade publication for pharmacists, Pharmacy Learning Network, quotes the recall wording as a product that “failed to meet dissolution specifications,” a laboratory standard that measures how much drug goes into solution over a set time. That standard exists because a tablet can pass every identity and strength test and still deliver its dose too slowly or too incompletely once swallowed.

Chlorthalidone’s job and a slow-releasing tablet

Chlorthalidone is described in its FDA-posted prescribing label as a monosulfamyl diuretic that differs chemically from thiazide diuretics. It increases sodium and chloride excretion through the kidneys by acting at the distal convoluted tubule, and the label credits that sodium and water depletion with its blood pressure effect. The label lists hypertension, alone or in combination, and swelling tied to congestive heart failure, liver cirrhosis, corticosteroid or estrogen therapy and kidney conditions including nephrotic syndrome and chronic renal failure.

The label also explains what separates this drug from its better-known relatives: its double-ring molecular structure sets it apart chemically from thiazide diuretics. The effect is long-acting: the label puts onset at about 2.6 hours after a dose and activity lasting up to 72 hours. Because a single daily tablet is expected to do that work, a dissolution shortfall bears directly on the one thing the drug is prescribed for, controlling pressure and fluid.

Pharmacy Learning Network’s account describes the recommended pharmacist response as identifying and quarantining the affected lots, removing them from inventory and working with prescribers to supply alternative medication. The same account notes that the recall was communicated by letter from the manufacturer and that no press release was distributed.

Class II and the dates that do not match

FDA’s Enforcement Report page explains that the three recall classes indicate the relative health hazard, and that a recall is “not yet classified” until the agency finishes its hazard assessment. The page adds that classifications are most often determined after the recalling firm supplies all the information needed to judge the risk to public health, which is why the rating can lag the start of a recall by weeks. AARP defines Class II as a recall where temporary or medically reversible health consequences are possible. Pharmacy Learning Network gives the same definition, with a low probability of serious harm.

The reports disagree on timing and on size. AARP’s article is dated September 2026 and covers three lots. Pharmacy Learning Network lists a recall initiation date of June 5, 2026 and an FDA classification date of June 22, 2026 for two lots, RISA24001 and RISB24002, totaling 11,460 bottles. An ABC-affiliated station’s report also gives June 5, 2026, with the FDA classification not yet assigned when it was written.

The entry that would settle the dates and the lot list is the one in the weekly Enforcement Report. FDA’s recalls, market withdrawals and safety alerts table, current to October 3, 2026, carried no chlorthalidone item, and the table is a list of notices rather than a full record of every recall. No date is therefore attached here to the recall of the full three-lot set. What the sources agree on is the product, the distributor, the manufacturer, the Class II rating and the reason: tablets that may not dissolve as they should.

The unresolved point is the bottle count. AARP gives more than 25,000 bottles across three lots, while the pharmacy trade report stops at 11,460 bottles in two lots, and the FDA record that reconciles the two had not surfaced in the pages read.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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