Saxagliptin 5mg Tablets Recalled for Manufacturing Practice Deviations
Glenmark Pharmaceuticals is voluntarily recalling Saxagliptin 5mg tablets nationwide due to CGMP deviations. Affected lot numbers are 17232460 and 17241194.
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 Class II recall with no reported illnesses, injuries, or deaths. The source describes CGMP deviations without detailing a specific acute safety hazard, and the recall is classified as voluntary precautionary in nature.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Saxagliptin 5mg tablets distributed nationwide. The recall affects 30-count bottles (NDC# 68462-727-30) and 90-count bottles (NDC# 68462-727-90). Affected lot numbers are 17232460 (expiration November 2025) and 17241194 (expiration June 2026).
The FDA classified this as a Class II recall due to CGMP (Current Good Manufacturing Practice) deviations identified at the manufacturing facility. The recall was initiated by Glenmark on March 13, 2025.
Patients currently taking Saxagliptin from the affected lot numbers should consult their healthcare provider or pharmacist. Do not stop taking your medication without consulting your doctor, as Saxagliptin is used to treat type 2 diabetes, and stopping abruptly could affect blood sugar control.
The recalled product
- Product
- SAXAGLIPTIN (SAXAGLIPTIN)
- Brand
- SAXAGLIPTIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Diabetes medication
- Hazard
- manufacturing-deviation
- 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 # 17232460
- exp. date Nov-25 17232460
- exp. date Nov-25 17241194
- exp. date Jun-26 17241194
- exp. date Jun-26
Distribution
Distributed nationwide across the United States.
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