Ranolazine Extended-Release Tablets Recalled for Failed Dissolution Specifications
Glenmark Pharmaceuticals is recalling 16,944 bottles of Ranolazine 500mg tablets nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting drug efficacy.
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 recall with no reported illnesses or injuries. The hazard is a manufacturing defect affecting drug dissolution and bioavailability rather than an acute safety threat. Per the rubric, precautionary recalls without reported adverse events are typically scored at the Moderate level.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Ranolazine Extended-Release Tablets 500mg due to failed dissolution specifications. The affected lot (Lot #17230388, expiration 01/31/2025) did not meet required dissolution standards during quality control testing.
Ranolazine is a prescription medication used to treat chronic angina. Tablets that do not dissolve properly may not deliver the intended dose of medication, potentially reducing the drug's effectiveness in managing anginal symptoms.
This recall affects 16,944 bottles of the affected lot distributed nationwide. Patients currently taking Ranolazine should contact their pharmacist or healthcare provider to determine whether their supply is affected and discuss next steps.
Consumers should not stop taking their medication without consulting their healthcare provider. If you have Lot #17230388 with expiration date 01/31/2025, contact your pharmacy or physician to obtain replacement medication or discuss alternatives.
The recalled product
- Product
- RANOLAZINE (RANOLAZINE)
- Brand
- RANOLAZINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- dissolution-failure
- reduced-efficacy
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 # 17230388
- Exp. 01/31/2025
UPCs (2)
- 0368462320600
- 0368462319604
Distribution
Distributed nationwide across the United States.
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