Carvedilol Tablets Recalled Nationwide for Manufacturing Process Deviations
Glenmark Pharmaceuticals is voluntarily recalling Carvedilol 12.5 mg tablets nationwide due to manufacturing deviations found in the production process.
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: FDA Class II voluntary recall for manufacturing process deviations with no specific identified hazard. The absence of a concrete safety threat (contamination, defect, or adverse events) places this in the Moderate category rather than High.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Carvedilol Tablets, USP 12.5 mg in 500-count bottles distributed nationwide. The recall affects lots #17240238, #17240243, #17240245, and #17240248, all with an expiration date of January 2026, due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process.
The recall was initiated by the firm on March 13, 2025. The FDA confirmed the manufacturing deviations on April 8, 2025.
Carvedilol is a prescription medication used to treat heart failure and high blood pressure. Patients with any of the affected lots should contact their healthcare provider or pharmacist for guidance on whether their supply is affected and what steps to take. Patients should not discontinue the medication without consulting their healthcare provider, as abrupt discontinuation could lead to serious medical complications.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- 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 (5)
- Lot # 17240238
- exp. date Jan-26 17240243
- exp. date Jan-26 17240245
- exp. date Jan-26 17240248
- exp. date Jan-26
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
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