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Class II · ModerateActive recall

Potassium Chloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot# T05224; Exp. 02/2026
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand namePOTASSIUM CHLORIDE
Generic namePOTASSIUM CHLORIDE
Active ingredient(s)POTASSIUM CHLORIDE
Distributed by / forAurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520
NDC0904-7216-61
Show the full FDA record
Full product labelPotassium 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 firmThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
DistributionNationwide in the USA
Quantity6997 cartons
Recall initiated2025-01-30
Report date2025-02-12
Recall completed
Recall numberD-0221-2025
ClassificationClass II
FDA statusOngoing
Origin on fileLa Vergne TN United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.