Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC
Summary
The FDA issued a Class II for Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufacture by Inventia Healthcare Limited. Reason: Failed Dissolution Specifications.
Details
Source
Drug Recall
External ID
D-0852-2026
Action Date
2026-09-23
Status
Ongoing
Category
drug
Product Description
Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01
Lot/Code Info: Batch # RISA24002; Exp Date: 04/2027
Quantity Affected: 13567 bottles
Reason for Recall
Failed Dissolution Specifications
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-03
Company
Kalyan, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 17 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Inventia Healthcare Limited has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Inventia Healthcare Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Inventia Healthcare Limited have FDA actions?
Inventia Healthcare Limited has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0852-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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