The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0315-2025·Announced 2025-04-16

Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

Glenmark Pharmaceuticals Inc., USA is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects lot #17230819 with expiration date March 2025, distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 a Class II recall driven by CGMP manufacturing deviations. The source text does not report any illnesses or injuries, and CGMP deviations typically indicate potential quality issues rather than documented harm. This meets the criteria for a Moderate severity rating—manufacturing/labeling concerns without reported adverse health consequences.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Propafenone Hydrochloride Extended-Release Capsules 225mg in 60-count bottles (NDC# 68462-408-60) due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot is #17230819 with an expiration date of March 2025. The product was manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and distributed nationwide across the United States.

Propafenone hydrochloride is a prescription antiarrhythmic medication used to treat abnormal heart rhythms. CGMP deviations may affect product quality and consistency. Patients currently taking this medication should contact their healthcare provider or pharmacist to discuss whether they have a bottle from the affected lot and what steps to take.

Consumers who have this medication should check the lot number and expiration date on their bottle. If they have lot #17230819 (exp. Mar-25), they should contact their pharmacy or healthcare provider before taking any further doses. The company initiated this recall on March 13, 2025.

The recalled product

Product
PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
Brand
PROPAFENONE HYDROCHLORIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription / Antiarrhythmic
Hazard

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 # 17230819
  • exp. date Mar-25

UPCs (3)

  • 0368462409602
  • 0368462410608
  • 0368462408605

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 39 products in this recall →

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