Potassium Chloride Extended-Release Capsules — Class II drug recall D-0607-2024
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2024-07-24, distributed nationwide. CGMP Deviations
| Recall number | D-0607-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| 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) |
| Reason classes | cgmp |
| NDC | 68462-0357, 68462-0357-01, 68462-0357-05, 68462-0357-90 |
| Lot numbers | 17230186, 17230192, 17230213, 17230278, 17230399, 17230406, 17230412, 17230427, 17230444, 17230453, 17230495, 17230574, 17230585, 17230608, 17230629, 17230883, 17230921, 17231087, 17231339, 17231360, 17231711, 17231745, 17231819, 17231820, 17231936, 17231957, 17231998, 17232012, 17232110, 17232114, 17232119, 17232343, APR-30-25, AUG-31-25, DEC-31-24, FEB-28-25, JAN-31-25, JUL-31-25, JUN-30-25, MAR-31-25 and 2 more |
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
CGMP Deviations
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-0607-2024. 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.