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Drug FDA Class I Ongoing Failed specifications

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ

Glenmark Pharmaceuticals Inc., USA Published Jul 24, 2024

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Glenmark Pharmaceuticals Inc., USA or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications

Hazards

Failed Dissolution · primary

Affected products (1)

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01

POTASSIUM CHLORIDE · 285,840 bottles

NDC: 68462-357, 68462-357-90, 68462-357-01, 68462-357-05
Code info: Lot#: 17221446, 17221445, Exp May-31-24; 17221393, 17221403, 17221405, 17221503, 17221508, Exp Jun-30-24; 17221567, 17221566, 17221719, 17221731, Exp Jul-31-24; 17221891, 17221892, 17221900, 17221992, 17222022, Exp Aug-31-24; 17222056, 17222043, 17222068, 17222079, 17222099, 17222103, 17222114, 17222119, 17222188, 17222199, 17222209, 17222200, Exp Sep-30-24; 17222265, 17222269, Exp Oct-31-24; 17222527, 17222530, 17222583, 17222586, 17230051, 17230075, 17230067, Exp Nov-30-24;

Affected areas

Nationwide

Timeline

  1. Initiated
    May 30, 2024
  2. Published
    Jul 24, 2024
Recall number
D-0604-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.