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.
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: 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
- cgmp-deviation
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.
Related recalls
Same brand · GLIMEPIRIDE
- ModerateFDA Recalls Glimepiride Tablets for Misprint on Tablet
FDA (Drugs) · 2024-02-14
- ModeratePrescription Glimepiride Tablets Recalled Due to Tablet Misprint
FDA (Drugs) · 2024-02-14
- ModerateFDA Recalls Glimepiride Tablets for Manufacturing Deviations
FDA (Drugs) · 2023-05-03
- ModerateGlimepiride 2 mg tablets recalled for manufacturing practice deviations
FDA (Drugs) · 2023-03-08
- HighAccord Healthcare recalls Glimepiride tablets due to manufacturing practice deviations
FDA (Drugs) · 2023-03-08
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
- SevereAccucaine Lidocaine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08