The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0552-2023·Announced 2023-05-03

Prescription Drug Glimepiride Tablets Recalled Due to Manufacturing Deviations

Northwind Pharmaceuticals recalls specific lots of Glimepiride 4mg tablets due to manufacturing practice deviations. Affected tablets were distributed nationwide.

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: FDA Class II recall with no reported illnesses or injuries. Manufacturing practice deviations without specified health consequences classify as Moderate per the severity rubric.

Plain-English summary

Northwind Pharmaceuticals LLC is recalling specific lots of Glimepiride Tablets, USP 4mg, due to deviations from current Good Manufacturing Practice (CGMP). The affected products include 30-count bottles (NDC 51655-120-52) with lot numbers F105692201 (exp. 09/30/2024) and F105692203 (exp. 02/28/2025), and 90-count bottles (NDC 51655-120-26) with lot number F105692202 (exp. 02/28/2025). A total of 220 bottles have been distributed.

These products were distributed nationwide throughout the United States. The recall was initiated by the manufacturer on March 16, 2023, and was reported to the FDA on May 3, 2023.

Patients currently taking affected lots should consult with their healthcare provider or pharmacist. Patients should not discontinue this medication without medical guidance, as stopping a prescribed medication without supervision could be harmful. Healthcare providers and pharmacists should verify whether they have received affected lots and take appropriate action.

The recalled product

Product
GLIMEPIRIDE (GLIMEPIRIDE)
Brand
GLIMEPIRIDE
Manufacturer
Northwind Pharmaceuticals LLC
Category
Drug
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)

  • a) Lot #: F105692201
  • Exp. Date 09/30/2024
  • F105692203
  • Exp. Date 02/28/2025 b) Lot #: F105692202
  • Exp. Date 02/28/2025

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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