The Recall Desk
ModerateFDA (Drugs)·D-0551-2023·Announced 2023-05-03

FDA Recalls Glimepiride Tablets for Manufacturing Deviations

Northwind Pharmaceuticals is voluntarily recalling Glimepiride 2mg tablets distributed nationwide due to Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

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: Class II FDA recall for manufacturing compliance deviations. This is a voluntary, firm-initiated precautionary recall with no mentioned illnesses, injuries, or specific product defects identified, consistent with the Moderate severity category.

Plain-English summary

Northwind Pharmaceuticals LLC is recalling Glimepiride Tablets, USP 2mg, distributed nationwide in the United States. The recall affects 30-count bottles (NDC 51655-383-52) and 90-count bottles (NDC 51655-383-26).

The recall is due to Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. Affected lot numbers and expiration dates include: F106252201 (09/30/2024), F106252301 (5/31/2025), F106252303 (5/31/2025), F106252304 (07/31/2025), and F106252302 (07/31/2025).

This voluntary recall was initiated by the manufacturer on March 16, 2023. Patients currently taking Glimepiride should contact their healthcare provider or pharmacist if they have questions about whether their prescription is affected.

The recalled product

Product
GLIMEPIRIDE (GLIMEPIRIDE)
Brand
GLIMEPIRIDE
Manufacturer
Northwind Pharmaceuticals LLC
Category
Drug — Antidiabetic
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 (8)

  • a) Lot #: F106252201
  • Exp. Date 09/30/2024
  • F106252301
  • F106252303
  • Exp. Date 5/31/2025
  • F106252304
  • Exp. Date 07/31/2025 b) Lot #: F106252302
  • Exp. Date 07/31/2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Northwind Pharmaceuticals LLC 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 7 products in this recall →

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