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India-based Inventia Healthcare Ltd. initiated a voluntary chlorthalidone recall in September for 13,567 bottles of the 25-milligram tablets after Food and Drug Administration testing found the tablets failed dissolution standards. The recalled bottles contain 100 pills each, carry National Drug Code 64980-599-01 and show an April 2027 expiration. The FDA classified the action as Class II. The Mayo Clinic describes chlorthalidone as a diuretic commonly prescribed to lower blood pressure and to help remove excess fluid from the body. The report said it had contacted Inventia Healthcare for comment. Credit: Fox Business.
Key takeaways
- Inventia Healthcare Ltd. voluntarily recalled 13,567 bottles of 25-milligram chlorthalidone tablets after the FDA found dissolution failures.
- Each recalled bottle holds 100 pills, is marked with National Drug Code 64980-599-01, and carries an April 2027 expiration date.
- The FDA classified the action as Class II, signalling a risk of temporary or medically reversible health consequences.
- A previous recall in June affected more than 11,400 bottles for a similar dissolution issue.
Table of contents
Which product lots are involved and how large is the recall
The recall covers 13,567 bottles of chlorthalidone in the 25-milligram strength that Inventia Healthcare Ltd. pulled voluntarily after failing quality checks. Each pack contains 100 tablets and the recalled units are identified by National Drug Code 64980-599-01. The labelling on the affected inventory lists an April 2027 expiration date.
Manufacturers and regulators use the National Drug Code to match product, packaging and labelling. The NDC printed on the recalled bottles is the clearest single identifier supplied in the enforcement report; no additional lot numbers were provided in the public notice that accompanies the action.
The figure 13,567 is the count the enforcement report gives for this September recall, and it represents the number of individual bottles subject to the action rather than pill count or shipments.
Why the product was removed and what that means for patients
The recall followed dissolution testing that showed the tablets did not meet the agency's required dissolution performance. A dissolution failure means the drug may release its active ingredient more slowly or inconsistently than expected, which can reduce effectiveness for controlling blood pressure.
The FDA classified the recall as Class II, which the agency uses when a product's use may cause temporary or medically reversible health consequences or when serious adverse outcomes are unlikely. The enforcement report provided that classification rather than a narrative of individual patient events.
Mayo Clinic notes that chlorthalidone is prescribed to treat high blood pressure and fluid retention. For patients on this medicine, reduced dissolution could compromise blood-pressure control until a safe replacement is secured by a clinician or pharmacy.
Regulatory history and the manufacturer's response
This September action follows an earlier recall in June that affected more than 11,400 bottles and cited dissolution concerns as well. The repetition of a dissolution-related recall raises questions about the manufacturing or quality-control process that produced these lots.
Inventia Healthcare initiated the voluntary recall identified in the enforcement report. The company is named on the notice and the enforcement record is the public source for the counts, product identifiers and the agency classification.
The enforcement notice is the mechanism the FDA uses to make recall details public; it lists the product identifiers and the regulator's classification. The report indicated it had contacted Inventia Healthcare for comment.
| Recall month | Bottles affected | Reason cited | Dosage | NDC | Expiration |
|---|---|---|---|---|---|
| June | more than 11,400 | dissolution issues | 25 mg | ||
| September | 13,567 | dissolution issues | 25 mg | 64980-599-01 | April 2027 |
How the situation could evolve
The case for
- The manufacturer's voluntary action and the FDA's Class II designation lower the immediate probability of widespread, severe harm if affected pills are identified and removed from use.
- Public enforcement records and product identifiers such as the NDC allow pharmacies and clinicians to match and withdraw affected stock more quickly.
The case against
- A repeat dissolution failure — June followed by September — suggests unresolved manufacturing quality-control gaps that could prompt broader recalls if other lots test similarly.
- If patients continue to use affected bottles unknowingly, some may experience suboptimal blood-pressure control until the issue is identified and their therapy is reviewed.
What to be careful about
- Patients using affected bottles could receive subtherapeutic dosing because tablets failed dissolution testing.
- Remaining inventory in homes or small pharmacies could prolong exposure unless the specific NDC and expiration are checked and removed.
- A continued pattern of dissolution failures may indicate systemic quality problems at the manufacturing site, risking further recalls.
The bottom line
The FDA enforcement entry and the manufacturer's voluntary notice together identify 13,567 bottles of 25-milligram chlorthalidone as the subject of the September recall, with the units carrying NDC 64980-599-01 and an April 2027 expiration. The agency characterised the action as Class II and a June recall for dissolution problems affected more than 11,400 bottles. The immediate priorities are clarification of any additional lot identifiers from the manufacturer and guidance from regulators or clinicians for patients holding the cited product.
What to watch
- Look for an updated FDA enforcement report or recall notice with additional lot numbers or supplier details; no date has been set.
- Check for any corrective-action statement or public recall update from Inventia Healthcare; no date has been set.
Frequently asked questions
How many chlorthalidone bottles were recalled?
The enforcement record lists 13,567 bottles recalled in the September action.
Who issued the recall?
India-based Inventia Healthcare Ltd. initiated the voluntary recall that appears in the FDA enforcement notice.
What product identifiers should I check?
The affected bottles are 25-milligram chlorthalidone, marked with National Drug Code 64980-599-01 and an April 2027 expiration.
Related reading
This article is information, not medical advice. Anyone acting on it should speak to a qualified professional.
