Nitroglycerin Sublingual Tablets Recalled for CGMP Deviations
Glenmark Pharmaceuticals Inc., USA is recalling Nitroglycerin Sublingual Tablets 0.4 MG due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lot numbers distributed nationwide.
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 recalls are typically scored 2–4 depending on reported illness or serious outcomes. The source text indicates only CGMP deviations without any reported adverse health effects or illnesses, placing this at the lower end; this is a precautionary recall based on manufacturing process issues.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Nitroglycerin Sublingual Tablets 0.4 MG in 100-count cartons (NDC# 68462-639-45) due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots are Lot #17232024 (expiration Aug-25), Lot #17232071 (expiration Sep-25), and Lot #17232072 (expiration Sep-25). The product was distributed nationwide in the United States.
Consumers taking this medication should contact their healthcare provider or pharmacist to discuss their treatment options. Do not stop taking nitroglycerin without medical guidance, as this is a critical medication for managing heart conditions. Healthcare providers should verify whether their patients have received affected lots and may request return or destruction of the product.
This is a voluntary recall initiated by the firm on March 13, 2025. The FDA classified this as a Class II recall on April 8, 2025.
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 (4)
- Lot # 17232024
- exp. date Aug-25 17232071
- exp. date Sep-25 17232072
- exp. date Sep-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.
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