The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0351-2025·Announced 2025-04-16

Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

Glenmark Pharmaceuticals is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg (Lot #17230819) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and initiated by the manufacturer.

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 for CGMP deviations. The source text does not report any illnesses, injuries, hospitalizations, or actual product failures—only manufacturing process deficiencies. Per the rubric, the score is at most 3 when no illnesses or injuries are reported and the hazard remains theoretical; this qualifies as a Moderate (2) voluntary precautionary recall.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Propafenone Hydrochloride Extended-Release Capsules USP 225mg in 60-count bottles (NDC# 16714-825-01) from the U.S. nationwide. The affected lot is #17230819 with an expiration date of March 2025. The product is manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. This is a voluntary recall initiated by the firm, classified by the FDA as Class II.

Patients taking this medication should consult their healthcare provider regarding continued use. Healthcare providers and patients with questions may contact the FDA or the recalling manufacturer for additional information.

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 # 17230819
  • exp. date Mar-25

UPCs (2)

  • 0316714826011
  • 0316714827018

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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