FDA Recall D-0221-2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · La Vergne, TN

Class II Ongoing 469 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot# T05224; Exp. 02/2026

Quantity: 6997 cartons

Reason for recall

Failed Dissolution Specifications.

Recall record

Recall number: D-0221-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-01-30
Classified by FDA Center: 2025-02-04
FDA published: 2025-02-12
Recalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Firm location: La Vergne, TN

Drug identification

Brand name(s): POTASSIUM CHLORIDE
Generic name(s): POTASSIUM CHLORIDE
Manufacturer(s): Major Pharmaceuticals
NDC(s): 0904-7216
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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