FDA Drugs recall ·
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg)… recall
- Recall number
- D-0221-2025
- Date
- (initiated January 30, 2025)
- Company / brand
- Major Pharmaceuticals and Rugby Laboratories
341 Mason Rd, La Vergne, TN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6997 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Dissolution Specifications.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# T05224; Exp. 02/2026
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0221-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.