Nitroglycerin Sublingual Tablets Recalled for CGMP Deviations
Glenmark Pharmaceuticals Inc. is recalling specific lots of Nitroglycerin 0.3MG sublingual tablets distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. Patients should consult their healthcare provider.
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: The FDA classified this as Class II, and the source text explicitly states CGMP deviations without any reports of illness or injury. No hospitalization or adverse health events are documented, making this a precautionary recall for manufacturing process defects.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Nitroglycerin Sublingual Tablets 0.3MG in 100-count bottles due to Current Good Manufacturing Practice (CGMP) deviations. The affected product, manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, was distributed nationwide.
The following lots are affected: Lot #17232361 (expiration Nov-25), Lot #17232367 (expiration Nov-25), Lot #17240037 (expiration Dec-25), and Lot #17240038 (expiration Dec-25). The product carries NDC# 68462-638-01.
Patients should not abruptly discontinue this medication without consulting their healthcare provider, as nitroglycerin is used to manage serious cardiovascular conditions. Healthcare providers and patients in possession of affected lots should contact their pharmacy or Glenmark Pharmaceuticals Inc. for guidance on obtaining replacement product or alternative therapies.
The recalled product
- Product
- NITROGLYCERIN (NITROGLYCERIN)
- Brand
- NITROGLYCERIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- 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 (5)
- Lot # 17232361
- exp. date Nov-25 17232367
- exp. date Nov-25 17240037
- exp. date Dec-25 17240038
- exp. date Dec-25
UPCs (3)
- 0368462638019
- 0368462639016
- 0368462640012
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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