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Class II · ModerateActive recall

Propafenone Hydrochloride

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

Does this affect you?
Check your lot numberLot # 17230819, exp. date Mar-25
Where it was soldU.S. Nationwide
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

CGMP Deviations

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 byNorthstar Rx LLC
Brand namePROPAFENONE HYDROCHLORIDE
Generic namePROPAFENONE HYDROCHLORIDE
Active ingredient(s)PROPAFENONE HYDROCHLORIDE
Distributed by / forGlenmark Pharmaceuticals Inc., USA
NDC16714-825-01
Show the full FDA record
Full product labelPropafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.
Recalling firmGlenmark Pharmaceuticals Inc., USA
DistributionU.S. Nationwide
QuantityN/A
Recall initiated2025-03-13
Report date2025-04-16
Recall completed—
Recall numberD-0351-2025
ClassificationClass II
FDA statusOngoing
Origin on fileMahwah NJ United States

Related

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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.