Nitroglycerin Sublingual Tablets Recalled for Manufacturing Practice Deviations
Glenmark Pharmaceuticals is recalling nitroglycerin sublingual tablets nationwide due to manufacturing practice deviations. Affected lots expire in November and December 2025; no illnesses have been reported.
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 a voluntary, firm-initiated recall for manufacturing practice deviations with no reported illnesses or injuries. The recall meets the criteria for Moderate severity as a precautionary recall, consistent with FDA Class II classification, without evidence of actual adverse events.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA, is recalling Nitroglycerin Sublingual Tablets 0.3MG due to deviations in current good manufacturing practices (CGMP). The recall includes 100-count bottles manufactured in India and distributed nationwide in the United States.
The affected lots are: 17232361 and 17232367 (November 2025 expiration date) and 17240037 and 17240038 (December 2025 expiration date). The product is identified by NDC# 68462-638-01 and related package codes. The manufacturer is located in Mahwah, New Jersey.
This is a voluntary recall initiated by the manufacturer on March 13, 2025. The FDA classified this recall as Class II. No illnesses or injuries related to these products have been reported. Patients taking affected products should consult their healthcare provider or pharmacist immediately to verify whether their prescription is among the recalled lots and to discuss alternative medication options.
The recalled product
- Product
- NITROGLYCERIN (NITROGLYCERIN)
- Brand
- NITROGLYCERIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- manufacturing-defect
- cgmp-violation
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.
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- ModerateGlenmark Nitroglycerin sublingual tablets recalled for manufacturing deviations
FDA (Drugs) · 2025-04-16
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