Recall archive / FDA drug enforcement

Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180... — FDA record D-0089-2022

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 Oct 12, 2021. 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: Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
Reason: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Classification: Class II
Recalling firm: Lupin Pharmaceuticals Inc.
Quantity: 63,408 bottles
Agency-reported status: Terminated
Source record identifier: D-0089-2022

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	a) Lot# H804537, exp. date 30/09/2021 H805148, exp. date 31/10/2021 H900063, exp. date 31/10/2021 H900522, exp. date 31/12/2021 H901582, exp. date 31/01/2022 b) Lot# H000963, exp. date 30/04/2022 H804507, exp. date 30/04/2022 H804536, exp. date 30/09/2021 H805070, exp. date 31/10/2021 H805149, exp. date 31/10/2021 H900064, exp. date 31/12/2021 H900523, exp. date 31/01/2022 H901583, exp. date 30/04/2022 H902530, exp. date 30/04/2022

Label field

Details supplied by the agency

Lot, code or applicability

a) Lot# H804537, exp. date 30/09/2021 H805148, exp. date 31/10/2021 H900063, exp. date 31/10/2021 H900522, exp. date 31/12/2021 H901582, exp. date 31/01/2022 b) Lot# H000963, exp. date 30/04/2022 H804507, exp. date 30/04/2022 H804536, exp. date 30/09/2021 H805070, exp. date 31/10/2021 H805149, exp. date 31/10/2021 H900064, exp. date 31/12/2021 H900523, exp. date 31/01/2022 H901583, exp. date 30/04/2022 H902530, exp. date 30/04/2022

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

Distribution

Product was distributed to major distributors who may have further distributed the product nationwide.

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: Nov 10, 2021
Recall initiation date: Oct 12, 2021
Center classification date: Nov 1, 2021
Termination date: Jan 30, 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.