Potassium Chloride Extended-Release Capsules — Class I drug recall D-0604-2024

Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2024-07-24, distributed nationwide. Failed Dissolution Specifications

Recall number	`D-0604-2024`
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	285,840 bottles
Reason classes	specification failure
NDC	`68462-0357`, `68462-0357-01`, `68462-0357-05`, `68462-0357-90`
Lot numbers	`17221393`, `17221403`, `17221405`, `17221445`, `17221446`, `17221503`, `17221508`, `17221566`, `17221567`, `17221719`, `17221731`, `17221891`, `17221892`, `17221900`, `17221992`, `17222022`, `17222043`, `17222056`, `17222068`, `17222079`, `17222099`, `17222103`, `17222114`, `17222119`, `17222188`, `17222199`, `17222200`, `17222209`, `17222265`, `17222269`, `17222527`, `17222530`, `17222583`, `17222586`, `17230051`, `17230067`, `17230075`, `AUG-31-24`, `JUL-31-24`, `JUN-30-24` and 4 more

Product

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

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-0604-2024. 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.