Potassium Chloride Extended-Release Capsules — Class I drug recall D-0619-2024
Ongoing recall by Amerisource Health Services LLC, reported 2024-08-07, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0619-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2024-06-25 |
| Classified | 2024-07-28 |
| Reported by FDA | 2024-08-07 |
| Distributed | Nationwide (US) |
| Quantity | 61,231 bottles |
| Reason classes | specification failure |
| NDC | 68001-0396, 68001-0396-00, 68001-0396-03 |
| Lot numbers | 17221738, 17221823, 17221830, 17221831, 17222494, 17230248, 17230253, 17230271, 17230533, 17230796, 17230820, 17230825, 17230833, 17230840, 17231537, 17231540, 17231719, 17231737, 17232111, 17232164, 17232208 |
| Expiration dates | 2024-07-31, 2024-08-31, 2024-10-31, 2024-12-31, 2025-01-31, 2025-02-28, 2025-03-31, 2025-06-30, 2025-09-30 |
Product
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
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-0619-2024. 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.