Glenmark Recalls Potassium Chloride Capsules Due to CGMP Deviations
Glenmark Pharmaceuticals recalls Potassium Chloride Extended-Release Capsules due to CGMP deviations. Check your lot numbers and expiration dates for affected batches.
Use caution until it’s fixed
CGMP Deviations
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What happened, in plain English
Glenmark Pharmaceuticals Inc., USA is recalling Potassium Chloride Extended-Release Capsules, USP (750 mg) because of Current Good Manufacturing Practice (CGMP) deviations. The record does not specify the exact nature of these deviations or list a specific remedy for consumers. Affected products include multiple lots with expiration dates ranging from May 2024 to August 2025. Read more at govinfonow.com/recall/32641-glenmark-recalls-potassium-chloride-capsules-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/32641-glenmark-recalls-potassium-chloride-capsules-due-to-cgmp-deviations · Updated October 9, 2026 · FDA enforcement record: FDA #D-0606-2024
Cite this page
“Glenmark Recalls Potassium Chloride Capsules Due to CGMP Deviations.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32641-glenmark-recalls-potassium-chloride-capsules-due-to-cgmp-deviations. Based on FDA recall #D-0606-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0606-2024%22&limit=1).
Why it’s dangerous
The recall is due to CGMP deviations, which means the manufacturing process did not meet federal quality standards. While the specific defect is not described in the record, such deviations can potentially affect the strength, purity, or safety of the drug product.
Who’s affected
Patients who have been prescribed Potassium Chloride Extended-Release Capsules by Glenmark Pharmaceuticals Inc., USA. The record does not specify which specific health conditions or demographics are most at risk beyond those taking this medication.
How to tell if you have this one
Check your medication bottle for the brand Glenmark Pharmaceuticals Inc., USA. Look for NDC 68462-357-01 and one of the following lot numbers: 17230074, 17230221, 17230468, 17230479, 17230553, 17230543, 17230561, 17230619, 17230624, 17230879, 17230890, 17230918, 17230984, 17230996, 17231002, 17231081, 17231102, 17231135, 17231329, 17231369, 17231513, 17231516, 17231713, 17231909, 17231903, 17231943, 17232166, or 17232179. Verify the expiration date matches the lot (e.g., Lot 17230074 expires Dec-31-24).
- Brand
Glenmark- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Ongoing- Distribution
Nationwide- NDC
68462-357-90, 68462-357-01, 68462-357-05
| Recall number | Product, codes & lots | Quantity | Class |
|---|---|---|---|
| D-0604-2024 | 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; Lot#: 17221446, 17221445, Exp May-31-24; 17221393, 17221403, 17221405, 17221503, 17221508, Exp Jun-30-24; 17221567, 17221566, 17221719, 17221731, Exp Jul-31-24; 17221891, 17221892, 17221900, 17221992, 17222022, Exp Aug-31-24; 17222056, 17222043, 17222068, 17222079, 17222099, 17222103, 17222114, 17222119, 17222188, 17222199, 17222209, 17222200, Exp Sep-30-24; 17222265, 17222269, Exp Oct-31-24; 17222527, 17222530, 17222583, 17222586, 17230051, 17230075, 17230067, Exp Nov-30-24; | 285,840 bottles | Class I |
| D-0605-2024 | 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; 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; | 36,630 bottles | Class I |
| D-0606-2024 | 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; Lot #: 17230074, 17230221, Exp Dec-31-24; 17230468, 17230479, 17230553, 17230543, 17230561, Exp Jan-31-25; 17230619, 17230624, Exp Feb-28-25; 17230879, 17230890, 17230918, 17230984, 17230996, 17231002, 17231081, Exp Mar-31-25; 17231102, 17231135, 17231329, Exp Apr-30-25; 17231369, 17231513, Exp May-31-24; 17231516, 17231713, Exp Jun-30-25; 17231909, 17231903, Exp Jul-31-25; 17231943, Exp Aug-31-25; 17232166, 17232179, Exp Sep-30-25. | — | Class II |
| D-0607-2024 | 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; Lot #: 17230186, 17230192, 17230213, 17230278, 17230399, Exp Dec-31-24; 17230406, 17230412, 17230427, 17230444, 17230453, 17230495, Exp Jan-31-25; 17230574, 17230585, 17230608, 17230629, Exp Feb-28-25; 17230883, 17230921, Exp Mar-31-25; 17231087, 17231339, Exp Apr-30-25; 17231360, Exp May-31-25; 17231711, 17231745, Exp Jun-30-25; 17231819, 17231820, 17231936, 17231957, Exp Jul-31-25; 17231998, 17232012, Aug-31-25; 17232110, Exp Sep-30-25; 17232114, Exp Aug-31-25; 17232119, 17232343, Exp Sep-30-25. | — | Class II |
What to do — step by step
Check Your Medication
Compare your bottle's NDC, lot number, and expiration date against the list of recalled items in the record.
Contact Your Pharmacist
If you have an affected product, contact your pharmacist or healthcare provider for instructions on what to do next, as no specific remedy is listed in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0606-2024 (May 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0606-2024 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.