Class I · Most seriousActive recall
Potassium Chloride
A reasonable chance it could cause serious harm or death.
Does this affect you?
Check your lot numberLot #: 17221197, 17221386, 17221385, Exp May-31-24; 17221489, 17221504, 17221530, Exp Jun-30-24; 17221561, 17221579, 17221568, 17221702, 17221704, Exp Jul-31-24; 17221898, 17221993, 17222029, Exp Aug-31-24; 17222300, 17222304, 17222278, 17222609, 17222395, Exp Oct-31-24; 17222589, 17222605, 17222613, Exp Nov-30-24;
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Dissolution Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byGlenmark 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 foreign manufacturer
| Brand name | POTASSIUM CHLORIDE |
| Generic name | POTASSIUM CHLORIDE |
| Active ingredient(s) | POTASSIUM CHLORIDE |
| Distributed by / for | Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430 |
| NDC | 68462-357-05 |
Show the full FDA record
| Full product label | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-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 68462-357-05 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Distribution | Nationwide |
| Quantity | 36,630 bottles |
| Recall initiated | 2024-05-30 |
| Report date | 2024-07-24 |
| Recall completed | — |
| Recall number | D-0605-2024 |
| Classification | Class I |
| FDA status | Ongoing |
| Origin on file | Mahwah NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.