Potassium Chloride Extended-Release Tablets recall
FDA recall D-0221-2025 · initiated Jan 30, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Potassium Chloride Extended-Release Tablets in Jan 2025 — an FDA Class II recall (D-0221-2025) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
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: 6997 cartons
Details
- Product
- Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
- Recalling company
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 30, 2025
- FDA report date
- Feb 12, 2025
Frequently asked
- Was Potassium Chloride Extended-Release Tablets recalled?
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Potassium Chloride Extended-Release Tablets in Jan 2025 — an FDA Class II recall (D-0221-2025) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Potassium Chloride Extended-Release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0221-2025 was: Failed Dissolution Specifications.
- Is a recalled Potassium Chloride Extended-Release Tablets 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot# T05224; Exp. 02/2026. 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-0221-2025.