Prescription Cardiac Drug Recalled for Manufacturing Quality Deviations Nationwide
Glenmark Pharmaceuticals is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg nationwide due to Current Good Manufacturing Practice deviations. The firm-initiated voluntary recall affects a single lot (17230819, expiring March 2025).
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a cardiac medication with Current Good Manufacturing Practice deviations affecting nationwide distribution. No illnesses or injuries reported, but CGMP deviations on a prescription medication represent a direct risk of harm to patients dependent on this drug for heart rhythm management.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottles to the consumer level. The recall affects lot 17230819, with expiration date March 2025. Distribution was nationwide.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The firm initiated this voluntary recall and notified the FDA by letter on March 13, 2025.
Propafenone is a prescription antiarrhythmic medication used to treat certain heart rhythm conditions. Patients currently taking this medication should contact their healthcare provider or pharmacist to determine if they have the recalled product and discuss appropriate next steps.
Consumers who have this product should not use it and should consult their healthcare provider or pharmacist immediately for guidance.
The recalled product
- Product
- PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
- Brand
- PROPAFENONE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Cardiac Medication
- Hazard
- cgmp-deviation
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.
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Same brand · PROPAFENONE HYDROCHLORIDE
- ModeratePropafenone Hydrochloride Extended-Release Capsules Recalled for Manufacturing Deviations
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FDA (Drugs) · 2025-04-16
- HighDrug Recall: Propafenone Hydrochloride Capsules Due to Manufacturing Deviations
FDA (Drugs) · 2025-04-16
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