The Recall Desk
ModerateFDA (Drugs)·D-0352-2025·Announced 2025-04-16

Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

Glenmark Pharmaceuticals is voluntarily recalling Propafenone Hydrochloride Extended-Release Capsules 325mg (Lot #17230767, exp. Mar-25) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall (voluntary, firm-initiated) with no reported illnesses or injuries. The hazard is a manufacturing deviation without evidence of actual product harm, making this a precautionary recall that meets the criteria for Moderate severity.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Propafenone Hydrochloride Extended-Release Capsules, USP 325mg in 60-count bottles. The affected product is identified by NDC# 16714-826-01, Lot # 17230767, with an expiration date of March 2025. The recall was initiated on March 13, 2025, and is distributed U.S. Nationwide.

The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. Propafenone Hydrochloride is a prescription oral medication used to treat certain cardiac arrhythmias. The product was manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and distributed by Northstar Rx LLC, Memphis, Tennessee.

Patients taking this medication should consult their healthcare provider or pharmacist before discontinuing use or switching to an alternative product. Healthcare providers and pharmacists should not dispense this lot. The FDA has classified this as a Class II recall, which is ongoing.

For more information, consumers and healthcare professionals may contact the FDA or visit the FDA's Drug Recalls page.

The recalled product

Product
PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
Brand
PROPAFENONE HYDROCHLORIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription Cardiac Antiarrhythmic
Hazard
  • cgmp-deviation
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 17230767
  • exp. date Mar-25

UPCs (3)

  • 0316714826011
  • 0316714827018
  • 0316714825014

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · PROPAFENONE HYDROCHLORIDE

Same category