CLASS I ONGOING Drug recall · Reported 24 Jul 2024 · FDA Enforcement Report

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K recalled

Glenmark Pharmaceuticals Inc., U is recalling Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, distributed nationwide in the US. The recall was initiated on 30 May 2024 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: 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;

NDC68462-357

Quantity recalled36,630 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0605-2024
FDA event ID: 94715
Recalling firm: Glenmark Pharmaceuticals Inc., U, Mahwah, NJ
Brand: Potassium Chloride
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Classification: Class I
Status: Ongoing
Recall initiated: 30 May 2024
FDA classified: 17 Jul 2024
Reported: 24 Jul 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Injectable & IV Drugs

Timeline

30 May 2024	Recall initiated by company
17 Jul 2024	Classified by FDA	+48 days
24 Jul 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Is Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K recalled?

Yes. Glenmark Pharmaceuticals Inc., U recalled Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K on 30 May 2024. The recall is Class I and its status is Ongoing. Recall number D-0605-2024.

Why was it recalled?

Failed Dissolution Specifications

Which lots are affected?

Lot #: 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 was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Potassium Chloride recalls

All 21

Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
19 Mar 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in flexible container recalledPotassium Chloride	ICU Medical	Labeling Errors	Nationwide
19 Mar 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total recalled by ICU MedicalPotassium Chloride	ICU Medical	Other	Nationwide
12 Feb 2025Drug	CLASS II	Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium Chloride	The Harvard Drug Group	Potency & Assay	Nationwide