Potassium Chloride Extended Release Capsules Recalled for Dissolution Defect
RemedyRepack Inc. is recalling Potassium Chloride Micro 10mEq K Extended Release Capsules because they fail to meet dissolution specifications, which could affect medication effectiveness.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a manufacturing defect affecting medication dissolution, with no documented adverse health events. This meets the rubric for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
RemedyRepack Inc. is recalling Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules due to CGMP (Current Good Manufacturing Practice) deviations. The capsules do not meet dissolution specifications, meaning the medication may not be released in the body as designed.
The recalled product consists of 142 blister cards (30 capsules per card) distributed nationwide. The affected lot numbers are J0758674-021824 (expiration 03/31/2025) and J0751898-011424 (expiration 01/31/2025).
Patients should contact their healthcare provider regarding this recall. Because this is a prescription medication, patients should not discontinue use without consulting their doctor.
The recalled product
- Product
- Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Electrolyte supplement
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: J0758674-021824
- Exp 03/31/2025
- J0751898-011424
- Exp 01/31/2025
Distribution
Distributed nationwide across the United States.
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