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.
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: 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
Same brand · NITROGLYCERIN
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- ModerateNitroglycerin Sublingual Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2025-04-16
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateGlenmark Naproxen Sodium Tablets recalled for CGMP deviations
FDA (Drugs) · 2021-09-29
- HighPrescription chlorpromazine tablets recalled due to manufacturing quality defect
FDA (Drugs) · 2025-01-01
- ModerateGlenmark Naproxen Sodium 550 mg Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2021-09-29
- ModerateClindamycin Hydrochloride Capsules Recalled for cGMP Deviations
FDA (Drugs) · 2025-05-07
- HighGlenmark carvedilol 25 mg tablets exceed the acceptable nitrosamine intake level
FDA (Drugs) · 2025-08-20
- SevereGlenmark Recalls Ranitidine Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-01-15