An India-based pharmaceutical company has voluntarily recalled a common blood pressure medication sold across the United States after the drug failed a key quality test.
Inventia Healthcare Limited initiated a recall of Chlorthalidone Tablets, USP, 25 mg on Sept. 3, after the product failed dissolution specifications. The recall affects approximately 13,567 bottles — each containing 100 tablets — distributed nationwide.
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What is being recalled
The recalled product is Chlorthalidone Tablets, USP, 25 mg, sold in 100-count bottles under NDC 64980-599-01. The affected batch number is RISA24002, with an expiration date of April 2027. The recall is identified by the number D-0852-2026.
The U.S. Food and Drug Administration classified the recall as Class II on Sept. 17, 2026 — a designation that indicates the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Why it matters
Dissolution testing measures how well a tablet breaks down and releases its active ingredient in the body. When a drug fails this test, it may not be absorbed properly.
According to the Cleveland Clinic, CHLORTHALIDONE (klor THAL i done) treats high blood pressure. It may also be used to reduce swelling related to heart, kidney, or liver disease. It helps your kidneys remove more fluid and salt from your blood through urine. It belongs to a group of medications called diuretics.
What patients should do
The recall is ongoing and was firm-initiated, meaning Inventia Healthcare voluntarily triggered the action.
Patients who have been prescribed chlorthalidone tablets should check whether their medication is part of the affected batch and contact their pharmacist or prescribing physician.
Healthcare providers and pharmacists can also report adverse events related to this product to the FDA’s MedWatch program at 1-800-FDA-1088.