Propafenone Hydrochloride Capsules Recalled Due to Manufacturing Deviations
Glenmark Pharmaceuticals recalls Propafenone Hydrochloride Extended-Release Capsules (325mg) nationwide due to manufacturing quality violations. Affected lot #17230767 expires March 2025.
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 for manufacturing quality deviations with no reported illnesses, injuries, or deaths. Class II recalls without reported hospitalizations are classified as Moderate per the severity rubric.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Propafenone Hydrochloride Extended-Release Capsules, USP 325mg in 60-count bottles due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a Class II recall. The affected lot is #17230767, which expires in March 2025.
The product was distributed nationwide in the United States. It was manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, for Northstar Rx LLC in Memphis, Tennessee. The NDC number is 16714-826-01.
Patients currently taking this medication should contact their healthcare provider or pharmacist to determine if their supply is from the recalled lot by checking the lot number. Do not stop taking this medication without consulting a healthcare provider first.
The manufacturer voluntarily initiated this recall on March 13, 2025, and the FDA classified the recall on April 8, 2025.
The recalled product
- Product
- PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
- Brand
- PROPAFENONE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- 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 # 17230767
- exp. date Mar-25
UPCs (3)
- 0316714826011
- 0316714827018
- 0316714825014
Distribution
Distributed nationwide across the United States.
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