CLASS II ONGOING Drug recall · Reported 24 Jun 2026 · FDA Enforcement Report
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr recalled
Inventia Healthcare is recalling Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr, distributed nationwide in the US. The recall was initiated on 5 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0610-2026
- FDA event ID
- 99136
- Recalling firm
- Inventia Healthcare, Kalyan
- Brand
- Chlorthalidone
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jun 2026
- FDA classified
- 22 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 5 Jun 2026 | Recall initiated by company | |
| 22 Jun 2026 | Classified by FDA | +17 days |
| 24 Jun 2026 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10
Where it was distributed
U.S. Nationwide.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
[100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
Where was it sold?
U.S. Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Chlorthalidone recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Chlorthalidone Tablets, USP, 25 mg Unit Dose cards recalled by AvKAREChlorthalidone | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Chlorthalidone Tablets, USP, 25MG recalled by Cardinal HealthcareChlorthalidone | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Chlorthalidone Tablets USP 25 mg recalledChlorthalidone | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Chlorthalidone, Tablet, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Chlorthalidone, Tablet, 12.5 mg (1/2 of 25 mg) recalled | Aidapak Services | Labeling Errors | 4 states |