Potassium Chloride Extended-Release Capsules recall
FDA recall D-0605-2024 · initiated May 30, 2024
Glenmark Pharmaceuticals Inc., USA recalled Potassium Chloride Extended-Release Capsules in May 2024 — an FDA Class I recall (D-0605-2024) because Failed Dissolution Specifications.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 36,630 bottles
Details
- 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
- Recalling company
- Glenmark Pharms
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- May 30, 2024
- FDA report date
- Jul 24, 2024
Frequently asked
- Was Potassium Chloride Extended-Release Capsules recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Potassium Chloride Extended-Release Capsules in May 2024 — an FDA Class I recall (D-0605-2024) because Failed Dissolution Specifications. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Potassium Chloride Extended-Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0605-2024 was: Failed Dissolution Specifications
- Is a recalled Potassium Chloride Extended-Release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Potassium Chloride Extended-Release Capsules are affected?
- Distributed: Nationwide. The recall covers these lots — 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;. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0605-2024.