Potassium Chloride Extended-Release Capsules recall
FDA recall D-0619-2024 · initiated Jun 25, 2024
Amerisource Health Services LLC recalled Potassium Chloride Extended-Release Capsules in Jun 2024 — an FDA Class I recall (D-0619-2024) 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: 61,231 bottles
Details
- 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.
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jun 25, 2024
- FDA report date
- Aug 7, 2024
Frequently asked
- Was Potassium Chloride Extended-Release Capsules recalled?
- Amerisource Health Services LLC recalled Potassium Chloride Extended-Release Capsules in Jun 2024 — an FDA Class I recall (D-0619-2024) 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-0619-2024 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: US Nationwide.. The recall covers these lots — [100 count bottles]: Lot 17221738, Exp 07/31/2024; Lot 17222494, Exp 10/31/2024; Lot 17230533, Exp 01/31/2025; Lot 17232208, Exp 09/30/2025; [500 count bottles]: Lot 17221823, Lot 17221830, Exp 07/31/2024; Lot 17221831, Exp 08/31/2024; Lot 17230248, Lot 17230253, Lot 17230271, Exp 12/31/2024; Lot 17230796, Lot 17230820…. 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-0619-2024.