Potassium Chloride Tablets Recalled for Failed Dissolution Specifications
The FDA is recalling Potassium Chloride Extended-Release Tablets (10 mEq) distributed nationwide because they failed dissolution tests. This could affect how the medication is released in the body.
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: FDA Class II recall for failed dissolution specifications. While no illnesses or injuries are currently reported, dissolution failure in potassium supplements creates risk of therapeutic failure or improper drug delivery, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The FDA is recalling Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), produced by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. The tablets failed to meet dissolution specifications, which verify that the medication releases properly in the body over time.
The recall affects Lot # T05224 (expiration date 02/2026), approximately 6,997 cartons distributed nationwide throughout the United States. The tablets were distributed by Major Pharmaceuticals in Livonia, Michigan, and Aurobindo Pharma USA Inc. in East Windsor, New Jersey. The product is distributed under the brand name Potassium Chloride.
Patients currently taking this medication should not stop taking it without first consulting their healthcare provider. People with affected medications should contact their pharmacy or healthcare provider for guidance on obtaining replacement medication. Healthcare facilities and pharmacies should quarantine the affected lot and return or dispose of it according to FDA guidelines.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Category
- Drug
- Hazard
- Affected units
- 6,997
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 (2)
- Lot# T05224
- Exp. 02/2026
Distribution
Distributed nationwide across the United States.
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- Severe
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