Why it was recalled
Failed Dissolution Specifications
Product description
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
Lot numbers, UPCs & expiration codes
[100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
Where it was sold
U.S. Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0610-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 5, 2026
- FDA report date
- Jun 24, 2026
- Quantity
- 11,460 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Inventia Healthcare Limited
Original FDA data
Every field from FDA enforcement report D-0610-2026, exactly as published.
Show all FDA fields
- City
- Kalyan
- Status
- Ongoing
- Country
- India
- Event ID
- 99136
- Address
- Additional Ambernath Midc
- Address (line 2)
- Ambernath East; F1-F1/1-F75/1
- Code information
- [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
- Report date
- Jun 24, 2026
- Product type
- Drugs
- Recall number
- D-0610-2026
- Classification
- Class II
- Recalling firm
- Inventia Healthcare Limited
- Product quantity
- 11,460 bottles
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- Jun 5, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 22, 2026