Recall archive / FDA drug enforcement

Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by:... — FDA record D-0160-2023

Reported terminated

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 Nov 9, 2022. 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: Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10
Reason: Failed Impurity/Degradation Specifications
Classification: Class III
Recalling firm: Lannett Company Inc.
Quantity: 5,640 bottles
Agency-reported status: Terminated
Source record identifier: D-0160-2023

Open the official record

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

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lots: 20256318A (12/2022), 20256321A (12/2022), 21000238A (01/2023)

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

Distribution

Nationwide USA

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: Jan 25, 2023
Recall initiation date: Nov 9, 2022
Center classification date: Jan 16, 2023
Termination date: Jun 8, 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.