FDA DrugsClass II
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Ma...
Published: June 24, 2026Recall ID: D-0610-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Dissolution Specifications
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Kalyan |
| Openfda › Nui › 1 | N0000175359 |
| Openfda › Nui › 2 | N0000175420 |
| Openfda › Upc › 1 | 0364980599108 |
| Openfda › Upc › 2 | 0364980599016 |
| Openfda › Upc › 3 | 0364980600019 |
| Openfda › Unii | Q0MQD1073Q |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 197499 |
| Openfda › Rxcui › 2 | 197500 |
| Openfda › Spl id | 6404aaa7-05c8-4f96-a091-3f07248ffbd5 |
| Openfda › Brand name | CHLORTHALIDONE |
| Openfda › Spl set id | 71b1d074-0521-4cd1-beb5-fedd61f52eca |
| Openfda › Package ndc › 1 | 64980-599-01 |
| Openfda › Package ndc › 2 | 64980-599-10 |
| Openfda › Package ndc › 3 | 64980-600-01 |
| Openfda › Product ndc › 1 | 64980-599 |
| Openfda › Product ndc › 2 | 64980-600 |
| Openfda › Generic name | CHLORTHALIDONE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class pe | Increased Diuresis [PE] |
| Openfda › Substance name | CHLORTHALIDONE |
| Openfda › Pharm class epc | Thiazide-like Diuretic [EPC] |
| Openfda › Manufacturer name | Rising Pharma Holdings, Inc. |
| Openfda › Application number | ANDA211320 |
| Openfda › Is original packager | true |
| Event id | 99136 |
| Address 1 | Additional Ambernath Midc |
| Address 2 | Ambernath East; F1-F1/1-F75/1 |
| Code info | [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027 |
| Postal code | N/A |
| Report date | 20260624 |
| Product type | Drugs |
| Product quantity | 11,460 bottles |
| Reason for recall | Failed Dissolution Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260605 |
| Initial firm notification | Letter |
| Center classification date | 20260622 |
Overview
- Recalling FirmInventia Healthcare Limited
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide.