Recall archive / FDA drug enforcement

Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only — FDA record D-0088-2022

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 Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Reason: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Classification: Class II
Recalling firm: Lupin Pharmaceuticals Inc.
Quantity: 119,544 bottles
Agency-reported status: Terminated
Source record identifier: D-0088-2022

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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# H804310, exp. date 31/08/2021 H900050, exp. date 30/11/2021 H902262, exp. date 31/05/2022 b) Lot# H000845, exp. date 28/02/2023 H000846, exp. date 28/02/2023 H000965, exp. date 31/03/2023 H805345, exp. date 30/11/2021 H805346, exp. date 30/11/2021 H805347, exp. date 30/11/2021 H805724, exp. date 30/11/2021 H900061, exp. date 31/12/2021 H900062, exp. date 31/12/2021 H900445, exp. date 31/01/2022 H901489, exp. date 31/03/2022 H901490, exp. date 31/03/2022 H901491, exp. date 31/03/2022 H902261, exp. date 31/05/2022

Label field

Details supplied by the agency

Lot, code or applicability

a) Lot# H804310, exp. date 31/08/2021 H900050, exp. date 30/11/2021 H902262, exp. date 31/05/2022 b) Lot# H000845, exp. date 28/02/2023 H000846, exp. date 28/02/2023 H000965, exp. date 31/03/2023 H805345, exp. date 30/11/2021 H805346, exp. date 30/11/2021 H805347, exp. date 30/11/2021 H805724, exp. date 30/11/2021 H900061, exp. date 31/12/2021 H900062, exp. date 31/12/2021 H900445, exp. date 31/01/2022 H901489, exp. date 31/03/2022 H901490, exp. date 31/03/2022 H901491, exp. date 31/03/2022 H902261, exp. date 31/05/2022

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.