Inventia Healthcare Recalls 13,500 Chlorthalidone Bottles Over Dissolution Failures

4 min read
Source: New York Post
Inventia Healthcare Recalls 13,500 Chlorthalidone Bottles Over Dissolution Failures
Photo: New York Post
TL;DR

Inventia Healthcare Limited has voluntarily recalled 13,567 bottles of chlorthalidone 25 mg tablets after the medication failed dissolution testing. This is the second recall for this specific drug by the India-based manufacturer in 2026, following an earlier action in June. The FDA has classified the recall as Class II, indicating that while the risk of serious harm is remote, the product may cause temporary or medically reversible adverse health consequences. Patients are advised to consult their healthcare providers before stopping the medication, as abrupt discontinuation could lead to dangerous spikes in blood pressure.

Key points

  • Inventia Healthcare Limited voluntarily recalled 13,567 bottles of chlorthalidone 25 mg tablets (NDC: 64980-599-01) due to failures in dissolution testing, which measures how the drug dissolves in the body.
  • The FDA classified the recall as Class II, meaning the product may cause temporary or medically reversible adverse health consequences, but the probability of serious harm is considered remote.
  • This is the second recall for chlorthalidone by Inventia Healthcare in 2026; the first occurred in June and involved 11,460 bottles, bringing the total affected quantity to over 25,000 bottles.
  • The affected batches include codes RISA24001, RISB24002, and RISA24002, with an expiration date of April 2027. The recall numbers are D-0852-2026 and D-0610-2026.
  • Chlorthalidone is a diuretic used to treat high blood pressure and fluid retention. If the drug fails to dissolve properly, the active ingredient may not be absorbed effectively, potentially increasing the risk of stroke, heart attack, or kidney damage over time.
  • The FDA advises patients to continue taking the medication unless instructed otherwise by the recalling company, as abruptly stopping treatment can cause blood pressure to rise too quickly and lead to withdrawal symptoms or other complications.

Background

Chlorthalidone is a commonly prescribed diuretic for managing hypertension, a condition affecting approximately 119 million US adults. Recent guidelines from the American Heart Association and American College of Cardiology recommend early medication intervention for many patients. This recall follows a similar issue in June 2026 involving another manufacturer, Rising Pharma Holdings, highlighting ongoing quality control concerns in the supply of this essential medication.

How outlets are covering it

All three sources (New York Post, NBC 5 Dallas-Fort Worth, and USA Today) agree on the core facts: the recall involves 13,567 bottles of chlorthalidone 25 mg tablets by Inventia Healthcare, classified as Class II by the FDA. The New York Post emphasizes the potential long-term health risks of reduced drug efficacy, such as stroke and heart attack, and stresses the importance of not stopping the medication abruptly. NBC 5 Dallas-Fort Worth provides a broader context by noting that this is not the only recent blood pressure medication recall, citing a separate recall of Prazosin Hydrochloride in October 2025 over cancer-causing chemicals. USA Today focuses on the cumulative impact, noting that over 25,000 bottles have been recalled in total across the two actions, and reiterates the FDA's advice that patients should consult their doctors before discontinuing the drug, as stopping may be more harmful than continuing use of the recalled product.

Why it matters

The recall affects a widely used medication for hypertension, a condition that affects a significant portion of the US population. Dissolution failures can lead to inadequate drug absorption, potentially leaving patients unprotected against cardiovascular events. The recurrence of this issue with the same manufacturer within a short timeframe raises concerns about quality control in the pharmaceutical supply chain. Patients relying on this medication need to be aware of the recall to ensure they receive effective treatment and avoid potential health complications.

What to watch

Patients should check their medication bottles for the affected batch codes (RISA24001, RISB24002, RISA24002) and contact their healthcare providers or pharmacists for guidance. The FDA and Inventia Healthcare will likely monitor the situation for any adverse health reports. The FDA may continue to enforce strict quality control measures for the manufacturer to prevent future recalls. Patients should not stop taking the medication without medical advice, as this could lead to dangerous spikes in blood pressure.

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