Why it was recalled
Failed Dissolution Specifications
Product description
Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01
Lot numbers, UPCs & expiration codes
Batch # RISA24002; Exp Date: 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-0852-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 3, 2026
- FDA report date
- Sep 23, 2026
- Quantity
- 13567 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Inventia Healthcare Limited
Original FDA data
Every field from FDA enforcement report D-0852-2026, exactly as published.
Show all FDA fields
- City
- Kalyan
- Status
- Ongoing
- Country
- India
- Event ID
- 99806
- Address
- Additional Ambernath Midc
- Address (line 2)
- Ambernath East; F1-F1/1-F75/1
- Code information
- Batch # RISA24002; Exp Date: 04/2027
- Report date
- Sep 23, 2026
- Product type
- Drugs
- Recall number
- D-0852-2026
- Classification
- Class II
- Recalling firm
- Inventia Healthcare Limited
- Product quantity
- 13567 bottles
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Sep 3, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2026