The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0316-2025·Announced 2025-04-16

Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

Glenmark Pharmaceuticals Inc. is recalling Propafenone Hydrochloride Extended-Release Capsules 325mg (Lot #17230767, expiring Mar-25) distributed nationwide due to current Good Manufacturing Practice (CGMP) deviations. Patients taking this medication should consult their physician before discontinuing use.

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 an FDA Class II recall involving CGMP deviations in a prescription drug. The source text contains no reports of illness, injury, or adverse health consequences. Per the rubric, CGMP deviations without reported harm and with no high-risk pathogen or serious safety defect constitute a Moderate recall.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottles (NDC# 68462-409-60) distributed nationwide. The recall affects Lot #17230767 with an expiration date of March 2025.

The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The firm notified the FDA by letter on March 13, 2025, and the FDA classified this as a Class II recall on April 8, 2025.

Propafenone is a prescription antiarrhythmic medication used to treat abnormal heart rhythms. Patients currently taking this medication should not stop taking it without consulting their physician, as doing so could have serious health consequences. Affected patients should contact their pharmacy or healthcare provider for guidance on next steps or alternative sources of the medication.

Anyone with questions about this recall or who believes they have received affected product should contact Glenmark Pharmaceuticals Inc. USA at the address listed on the bottle or through the FDA's online resources.

The recalled product

Product
PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
Brand
PROPAFENONE HYDROCHLORIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription / Cardiovascular
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 # 17230767
  • 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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