Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0332-2025·Announced 2025-04-16

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.

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: 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.

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 →

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FDA Recalls Saxagliptin Tablets Due to Manufacturing Deviations
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