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.
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 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
- 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)
- 0316714826011
- 0316714827018
- 0316714825014
Distribution
Distributed nationwide across the United States.
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- ModeratePropafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations
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