Lupin recalls Irbesartan/Hydrochlorothiazide tablets with impurity risk
Lupin Pharmaceuticals recalls specific lots of Irbesartan and Hydrochlorothiazide tablets due to detected impurity N-nitrosoirbesartan in the manufacturing process.
Recall notice
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Contact the company
What happened, in plain English
Lupin Pharmaceuticals is recalling certain lots of Irbesartan and Hydrochlorothiazide tablets because they contain an impurity called N-nitrosoirbesartan. This impurity could pose a health risk, though the exact risk level isn't specified in the recall notice. Read more at govinfonow.com/recall/35694-lupin-recalls-irbesartan-hydrochlorothiazide-tablets-with-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35694-lupin-recalls-irbesartan-hydrochlorothiazide-tablets-with-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0090-2022
Cite this page
“Lupin recalls Irbesartan/Hydrochlorothiazide tablets with impurity risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35694-lupin-recalls-irbesartan-hydrochlorothiazide-tablets-with-impurity-risk. Based on FDA recall #D-0090-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0090-2022%22&limit=1).
Why it’s dangerous
The recall is due to the detection of an impurity called N-nitrosoirbesartan in the active pharmaceutical ingredient during manufacturing. This impurity could potentially cause health issues, but the specific health risks are not detailed in the recall notice.
Who’s affected
People who have the recalled lots of Irbesartan and Hydrochlorothiazide tablets (30-count or 90-count) from Lupin Pharmaceuticals. Those with prescription for these medications are most at risk.
How to tell if you have this one
Check for the product name 'Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg' with the specific lot numbers listed in the recall notice. These tablets are prescription-only and come in 30-count or 90-count bottles.
- Brand
Lupin- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Product was distributed to major distributors who may have further distributed the product nationwide.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0086-2022 | Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only; a) Lot# H000843, exp. date 28/02/2023 H805727, exp. date 30/11/2021 H901579, exp. date 31/03/2022 b) Lot# H000844, exp. date 28/02/2023 H000964, exp. date 31/03/2023 H804311, exp. date 31/08/2021 H805267, exp. date 30/11/2021 H805268, exp. date 30/11/2021 H805269, exp. date 30/11/2021 H805725, exp. date 30/11/2021 H805726, exp. date 30/11/2021 H901497, exp. date 31/01/2022 H901577, exp. date 31/03/2022 H901578, exp. date 31/03/2022 H902258, exp. date 31/05/2022 | 51,144 bottles | 68180-410-06, 68180-410-09, 68180-411-02, 68180-411-06, 68180-411-09, 68180-412-02, 68180-412-06, 68180-412-09 |
| D-0087-2022 | Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only; a) Lot# H804403, exp. date 31/08/2021 H805251, exp. date 30/11/2021 H805640, exp. date 30/11/2021 H901580; exp. date 30/04/2022 b) Lot# H804492, exp. date 31/08/2021 H805252, exp. date 30/11/2021 H805253, exp. date30/11/2021 H805641, exp. date30/11/2021 H805642, exp. date30/11/2021 H805643, exp. date 30/11/2021 H901581, exp. date 30/04/2021 H902139, exp. date 30/04/2022 H902140, exp. date 30/04/2022 | 134,016 bottles | 68180-410-06, 68180-410-09, 68180-411-02, 68180-411-06, 68180-411-09, 68180-412-02, 68180-412-06, 68180-412-09 |
| D-0088-2022 | Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only; 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 | 119,544 bottles | 68180-410-06, 68180-410-09, 68180-411-02, 68180-411-06, 68180-411-09, 68180-412-02, 68180-412-06, 68180-412-09 |
| D-0089-2022 | 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; 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 | 63,408 bottles | — |
| D-0090-2022 | Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only; a) Lot# H804192, exp. date 31/08/2021 H805348, exp. date 30/11/2021 H900065, exp. date 31/12/2021 H902264; exp. date 31/05/2022 b) Lot# H804082, exp. date 31/08/2021 H804121, exp. date 31/08/2021 H804338, exp. date 31/08/2021 H804538, exp. date 30/09/2021 H804539, exp. date 30/09/2021 H805349, exp. date 30/11/2021 H805350, exp. date 30/11/2021 H900066, exp. date 31/12/2021 H900067, exp. date 31/12/2021 H902265, exp. date31/05/2022 H902275, exp. date31/05/2022 H902276, exp. date31/05/2022 H902531, exp. date 30/04/2022 H902532, exp. date 30/04/2022 | 98,052 bottles | — |
What to do — step by step
Check Product Details
Look for the product name and lot numbers listed in the recall notice to confirm if your tablets are affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed to major distributors who may have further distributed the product nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0090-2022 (October 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0090-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.