Moderate riskFDA DrugClass II

Inventia chlorthalidone 25 mg tablets recalled for failed dissolution

Inventia Healthcare Limited's chlorthalidone 25 mg tablets failed to meet dissolution specifications, meaning the tablets may not break down properly in the body and deliver the full dose. This affects 100-tablet and 1000-tablet bottles distributed nationwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have chlorthalidone 25 mg tablets from Inventia Healthcare (NDC 64980-599-01 or 64980-599-10) with batch RISA24001 or RISB24002.
  2. Contact your pharmacist or doctor before stopping this blood pressure medication.
  3. Do not stop taking your chlorthalidone without medical guidance, as suddenly stopping can raise blood pressure.
  4. Return the recalled tablets to your pharmacy.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
11,460 bottles
Illnesses reported
None reported
Manufactured in
Additional Ambernath Midc, Ambernath East; F1-F1/1-F75/1, Kalyan, India
Classification
Class II
Recall number
D-0610-2026

In the FDA's words

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 Failed Dissolution Specifications [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027 Distribution: U.S. Nationwide. Affected quantity: 11,460 bottles
Hazard
Failed Dissolution Specifications

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