Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-... — FDA record D-0552-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 16, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Reason
CGMP Deviations
Classification
Class II
Recalling firm
Northwind Pharmaceuticals LLC
Quantity
a) 198 bottles; b) 22 bottles
Agency-reported status
Ongoing
Source record identifier
D-0552-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilitya) Lot #: F105692201, Exp. Date 09/30/2024; F105692203, Exp. Date 02/28/2025 b) Lot #: F105692202, Exp. Date 02/28/2025

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide with the United States

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
May 3, 2023
Recall initiation date
Mar 16, 2023
Center classification date
Apr 26, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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