Drug Recall: Ranolazine Extended-Release Tablets Due to Manufacturing Deviations
Glenmark Pharmaceuticals is recalling Ranolazine Extended-Release 1000mg tablets (Lot 17240040) nationwide due to manufacturing deviations. This is a voluntary, firm-initiated recall.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a Class II voluntary recall initiated by the manufacturer with no reported illnesses, injuries, or deaths. The recall is precautionary, based on manufacturing deviations without detailed hazard specifications.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Ranolazine Extended-Release Tablets 1000mg in 60-count bottles (Lot #17240040, expiration December 2025, NDC# 68462-320-60) distributed nationwide.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process.
Consumers with affected medication should consult their healthcare provider or pharmacist regarding this recall.
The recalled product
- Product
- RANOLAZINE (RANOLAZINE)
- Brand
- RANOLAZINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
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 # 17240040
- exp. date Dec-25
UPCs (2)
- 0368462320600
- 0368462319604
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 39 products in this recall →Related recalls
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