Potassium Chloride Extended-Release Capsules — Class I drug recall D-0605-2024
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2024-07-24, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0605-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2024-05-30 |
| Classified | 2024-07-17 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 36,630 bottles |
| Reason classes | specification failure |
| NDC | 68462-0357, 68462-0357-01, 68462-0357-05, 68462-0357-90 |
| Lot numbers | 17221197, 17221385, 17221386, 17221489, 17221504, 17221530, 17221561, 17221568, 17221579, 17221702, 17221704, 17221898, 17221993, 17222029, 17222278, 17222300, 17222304, 17222395, 17222589, 17222605, 17222609, 17222613, AUG-31-24, JUL-31-24, JUN-30-24, MAY-31-24, NOV-30-24, OCT-31-24 |
Product
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
Reason for recall
Failed Dissolution Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0605-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.