FDA Recalls Saxagliptin Tablets Due to Manufacturing Deviations
Glenmark Pharmaceuticals is recalling Saxagliptin 2.5mg tablets nationwide due to manufacturing quality issues. The firm initiated this voluntary recall on March 13, 2025.
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 an FDA Class II recall for manufacturing quality control deviations (CGMP) with no reported illnesses or injuries. The hazard is a quality control deviation rather than an acute safety risk.
Plain-English summary
Glenmark Pharmaceuticals Inc. USA is recalling Saxagliptin Tablets, USP 2.5mg nationwide. The recall affects 30-count bottles (NDC# 68462-726-30) and 90-count bottles (NDC# 68462-726-90) with lot numbers 17241788, 17241821, and 17241822, all with September 2026 expiration dates.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall initiated by the firm on March 13, 2025, and classified by the FDA as Class II. The tablets are manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and distributed throughout the United States.
No illnesses or adverse events have been reported in connection with this recall.
The recalled product
- Product
- SAXAGLIPTIN (SAXAGLIPTIN)
- Brand
- SAXAGLIPTIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- manufacturing-defect
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)
- 30-Count Bottle Lots: 17241788
- exp. date Sep-26 17241821
- exp. date Sep-26 17241822
- exp. date Sep-26 90-Count Bottle Lot: 17241822
- exp. date Sept 26
Distribution
Distributed nationwide across the United States.
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