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
- 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 (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.
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
- ModeratePrescription Drug Glimepiride Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2023-05-03
- HighAccord Healthcare recalls Glimepiride tablets due to manufacturing practice deviations
FDA (Drugs) · 2023-03-08
- ModerateGlimepiride 2 mg tablets recalled for 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
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27